GE 2001 IWS, 3050 IWS, 3100 IWS, 3000 IWS, 3150 IWS Service Manual
...
GE Healthcare
URGENT MEDICAL DEVICE CORRECTION
3000 N. Grandview Blvd.
-
W440
Safety
Hot screws from the
“Heater Head” of the IWS
could
fall onto
the bed
if the
“Heater Head” assembly has
Safety
The potential for this issue to occur is only present if the “Heater Head” assembly has been improperly
Affected
Refer to
Product Images
below
for
images of
A
ffected and Not affected
products
.
Rendered PDF File Page 2 of 4 DOC1881503, Rev:1
Waukesha, WI 53188, USA
<Date of Letter Deployment> GEHC Ref# 32047
To: Nurse Managers, Labor & Delivery/NICU
Bio-Medical Engineering Department Managers
Risk Management Directors
RE: Infant Warmer System (IWS) Hot “Heater Head” Screw could Fall onto the Bed
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the “Heater Head” of certain
Infant Warmer System (IWS) devices. Please ensure that all potential users, as well as those servicing these units, in your
facility are made aware of this safety notification and the recommended actions.
Issue
Instructions
Product
Details
been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient
could result. Two injuries have been reported as a result of this issue.
serviced.
As a result, if “Heater Head” service has been performed in the past, check to ensure that the screws are
tightened as soon as the unit becomes available.
If the “Heater Head” assembly has not been serviced, check to ensure that the screws are tightened as part
of your next regularly scheduled annual Preventive Maintenance check.
The attached Service Manual Addendum provides instructions for checking and tightening the screws.
During each annual Preventive Maintenance check, continue to ensure that the screws are tight.
Affected model numbers: Model 2001 IWS (International), 3000 IWS, 3050 IWS, 3100 IWS, 3150 IWS, 3300
IWS, 3500 IWS, 4000 IWS, 4300 IWS, 4400 IWS, 5000 IWS.
Affected Products Not Affected Products
Released
Page 1 of 3
Product
Attached to this letter
, we provide
instructi
ons
as part of a
Service Manual Addendum
on how to
correct
Contact
Rendered PDF File Page 3 of 4 DOC1881503, Rev:1
Correction
Information
Please be assured that maintaining a high level of safety and quality is our highest priority. If you have any questions, please
contact us immediately per the contact information above.
Sincerely,
James W. Dennison Jeff Hersh, M.D.
Vice President - Quality & Regulatory Chief Medical Officer
GE Healthcare GE Healthcare
the issue. Please add this new Addendum to the Service Manual of your device(s) and train the affected
users accordingly.
Please acknowledge that you have received this letter and that you understand that an action needs to be
taken on your part to correct this issue by filling out and returning the attached “Customer Response”
form.
If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at
1-800-437-1171 or your local Service Representative.
Released
Page 2 of 3
Please return this form using one of the following methods:
Rendered PDF File Page 4 of 4 DOC1881503, Rev:1
GE Healthcare
MEDICAL DEVICE CORRECTION CONFIRMATION GE REF: 32047
CUSTOMER RESPONSE REQUIRED
We request that you PLEASE COMPLETE and return this form to GE Healthcare within two (2) weeks.
Customer/Consignee Name: _____________________________________________________________
Street Address: _____________________________________________________________
City/State/ZIP/Country: _____________________________________________________________
Email Address: _____________________________________________________________
Phone Number: _____________________________________________________________
It is important that we confirm our customers have received this correction notice. Please check one of the following and complete the
requested information and send back via one of the methods below.
We acknowledge receipt and understanding of the Medical Device Correction Notice and have alerted the appropriate personnel
at our facility regarding the safety issue and instructions. We will perform the actions as requested in the attached Medical
Device Correction Notice on all potentially affected systems.
List all Device/System Serial Number(s) known (attachment can be used):__________________________________
_____________________________________________________________________________________________
_____________________________________________________________________________________________
We acknowledge receipt and understanding of the Medical Device Correction Notice and no longer have a system affected by this
Medical Device Correction Notice. (Please check appropriate disposition. If multiple systems or further information, attachment
can be used.)
Sold Returned Scrapped Other: _______________
Device/System Serial Number(s): ___________________________________________________
New Owner, if known: ____________________________________________________________
Contact Name: __________________________________________________________________
Street Address: __________________________________________________________________
City/State/Country: ______________________________________________________________
Contact (i.e. Email, Phone): _________________________________________________________
Please provide the name of the individual with responsibility for risk and compliance.
Signature: _____________________________________________________________
Printed Name: _____________________________________________________________
Title: _____________________________________________________________
Date (DD/MM/YYYY): _____________________________________________________________
1. Scan or take photo of completed form and email to MIC.Recall@ge.com
Note: QR code can be used to email the form: click QR code, attach photo to email, click Send
2. Take photo of completed form and send via SMS text to +1-410-972-8096
Note: QR code can be used to text the form: click QR code, attach photo to text, click Send
3. Fax completed form to Fax Number: +1-410-630-5938
QR (text)
QR (email)
Released
32047 – XXXX
Page 3 of 3
Addendum
2098189-001 A
Infant Warmer System Heater Reflector
Screws Maintenance Check
For future reference, add this addendum to your
Infant Warmer System Service Manual.
© 2016 General Electric Company
Language Disclaimer
(EN)
(BG)
(ZH-CN)
(ZH-HK)
(ZH-TW)
WARNING:
This service document is available in English only.
• If a customer’s service provider requires a language other than English, it is the customer’s
responsibility to provide translation services.
• Do not attempt to service the equipment unless this service manual has been consulted
and is understood.
• Failure to heed this warning may result in injury to the service provider, operator, or patient
from electric shock, mechanical hazards, or other hazards.
ПРЕДУПРЕЖДЕНИЕ
Това упътване за работа е налично само на английски език.
• Ако доставчикът на услугата на клиента изиска друг език, задължение на клиента е да
осигури превод.
• Не използвайте оборудването, преди да сте се консултирали и разбрали упътването за
работа.
• Неспазването на това предупреждение може да доведе до нараняване на доставчика
на услугата, оператора или пациентa в резултат на токов удар, механична или друга
опасност.
警告
本维修手册仅提供英文版本。
• 倘若客戶的服務供應商需要英文以外之服務手冊，客戶有責任提供翻譯服務。
•
除非已參閱本服務手冊及明白其內容，否則切勿嘗試維修設備。
•
不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的危險。
警告
本服務手冊僅提供英文版本。
• 倘若客戶的服務供應商需要英文以外之服務手冊，客戶有責任提供翻譯服務。
•
除非已參閱本服務手冊及明白其內容，否則切勿嘗試維修設備。
•
不遵從本警告或會令服務供應商、網絡供應商或病人受到觸電、機械性或其他的危險。
警告
本維修手冊僅有英文版。
• 若客戶的維修廠商需要英文版以外的語言，應由客戶自行提供翻譯服務。
•
請勿試圖維修本設備，除非 您已查閱並瞭解本維修手冊。
•
若未留意本警告，可能導致維修廠商、操作員或病患因觸電、機械或其他危險而受傷。
2 2098189-001 Rev A IWS Service Manual Addendum
VÝSTRAHA
WAARSCHUWING
(HR)
(CS)
(DA)
UPOZORENJE
Ovaj servisni priručnik dostupan je na engleskom jeziku.
• Ako davatelj usluge klijenta treba neki drugi jezik, klijent je dužan osigurati prijevod.
• Ne pokušavajte servisirati opremu ako niste u potpunosti pročitali i razumjeli ovaj servisni
priručnik.
• Zanemarite li ovo upozorenje, može doći do ozljede davatelja usluge, operatera ili pacijenta
uslijed strujnog udara, mehaničkih ili drugih rizika.
Tento provozní návod existuje pouze v anglickém jazyce.
• V případě, že externí služba zákazníkům potřebuje návod v jiném jazyce, je zajištění
překladu do odpovídajícího jazyka úkolem zákazníka.
• Nesnažte se o údržbu tohoto zařízení, aniž byste si přečetli tento provozní návod a
pochopili jeho obsah.
• V případě nedodržování této výstrahy může dojít k poranění pracovníka prodejního servisu,
obslužného personálu nebo pacientů vlivem elektrického proudu, respektive vlivem
mechanických či jiných rizik.
ADVARSEL
Denne servicemanual findes kun på engelsk.
• Hvis en kundes tekniker har brug for et andet sprog end engelsk, er det kundens ansvar at
sørge for oversættelse.
• Forsøg ikke at servicere udstyret uden at læse og forstå denne servicemanual.
• Manglende overholdelse af denne advarsel kan medføre skade på grund af elektrisk stød,
mekanisk eller anden fare for teknikeren, operatøren eller patienten.
(NL)
(ET)
Deze onderhoudshandleiding is enkel in het Engels verkrijgbaar.
• Als het onderhoudspersoneel een andere taal vereist , dan is de klant verantwoordelijk voor
de vertaling ervan.
• Probeer de apparatuur niet te onderhouden alvorens deze onderhoudshandleiding werd
geraadpleegd en begrepen is.
• Indien deze waarschuwing niet wordt opgevolgd, zou het onderhoudspersoneel, de
operator of een patiënt gewond kunnen raken als gevolg van een elektrische schok,
mechanische of andere gevaren.
IATUS
See teenindusjuhend on saadaval ainult inglise keeles
• Kui klienditeeninduse osutaja nõuab juhendit inglise keelest erinevas keeles, vastutab klient
tõlketeenuse osutamise eest .
• Ärge üritage seadmeid teenindada enne eelnevalt käesoleva teenindusjuhendiga tutvumist
ja sellest aru saamist .
• Käesoleva hoiatuse eiramine võib põhjustada teenuseosutaja, operaatori või patsiendi
vigastamist elektrilöögi, mehaanilise või muu ohu tagajärjel.
IWS Service Manual Addendum 2098189-001 Rev A 3
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