Getinge MEERA 720001B2, MEERA 720001B0, MEERA 720001F2, MEERA 710001B2, MEERA 710001B0 Field Safety Notice

Field Safety Notice

GETIFIGE

2019-04-02 I 2018-025

Please forward this information to all relevant users, [biomedical staff for
capital equipment, materials management and/or purchasing for consumables]
and risk management department concerned in your facility

Preventive Corrective Action: mobile OR-Table MEERA

Products affected:

Product
MEERA
MEERA

EU

with Drive Unit

EU

w/o Drive Unit
MEERA US with Drive Unit
MEERA US w/o Drive Unit
MEERA ST
MEERA ST

EU

Drive Unit

EU

w/o Drive Unit

MEERA ST US w/o Drive Unit

Article No.
720001B2
720001B0
720001F2
720001F0
710001B2
710001B0
710001F0

SIN No.
SN 1 to SN 416
SN 1 to SN 1416
SN 1 to SN 91
SN Ito SN 220
SN 1 to SN 8
SN 1 to SN 11
SN 1

Dear Customer

The purpose of this letter is to inform about a potential issue concerning the mobile OR-Table MEERA.
Our records indicate that your facility has received one or more of these devices.

Normal use and indications

The mobile OR-Table MEERA is designed to support and position the patient immediately before, during and
after surgical interventions as well as for examination and treatment.

The following has been discovered

As part of our post market surveillance, cases were reported to Getinge involving a mobile OR-Table MEERA,
and in which the plastic socket of the IEC 60320-1 socket was pulled out of the metal cage and electronic parts
were exposed. See Figure 1 below.

Potential hazards

In cases where the socket was pulled out and main cable is still connected to the main socket (power source),
there is a risk that a user or third person may suffer an electric shock when coming in contact with the exposed

electronic components.
Three cases have been reported to Getinge where the user received an electric shock. No permanent injury was

reported to Getinge in any of these cases.

MAQUET

GmbH

Kehler

Straße

31

76437 Rastatt, Germany
Phone: [phone]
Fax: [phone]
www.getinge.com

Gesellschaft mit beschränkter Haftung, Sitz: Rastatt
Registergericht Mannheim HRB 715072
Ust.-IdNr. DE 144021332

Steuer-Nr. 39487/29420
Geschäftsführer:

Aufsichtsratsvorsitzender: Frederic Fette

Dr.

Dieter Engel,

Dr.

Benno Bröcher

Sicherheitsbeauftragter.medizinprodukte©maquetde
Phone: [phone]

Fax: [phone]

Field Safety Notice' 2019-04-02 I 2018-025

Figure 1: Position mains connection on OR-Table / pulled out mains connection with exposed electronic

components/position of product label on mobile OR-Table MEERA including SN

Precautions

Until all actions have been accomplished, a visual and functional check is required to be performed by a trained

person before operation. Furthermore the information in the instructions for use (IFU) regarding connection to and

disconnecting from the mains socket (power source) should be observed as a matter of urgency. See figure 2

below.

Connecting to mains supply
GI Connect the supplied mains cable into the

mobile operating table (1).

E Then plug into the supply voltage socket.

.

7

The status display for mains operation

on the override control panel is lit up in
green

The rechargeable batteries of the mobile
operating table are charged.

.

7

The plug must always be accessible to

ensure that the OR table can be discon­nected from the power supply at any
time.

Detach the mains cable
[RI Detach the plug at the main socket.
Cl

Detach the mains cable from the mobile op-

erating table.

Figure 2: Abstract form IFU (establishing / separating the mains connection)

If the plastic socket of the cold-device plug is pulled out do not try to put it back into the housing and if there are

any exposed electronic components: do not touch them. Call your in-house technical service and arrange the
repair of the table.

www.getinge.com

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