Getinge MEERA 720001B2 - User Manual

Field Safety Notice
2019-04-02 I 2018-025
GETIFIGE
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
Article No.
SIN No.
MEERA
EU
with Drive Unit
720001B2
SN 1 to SN 416
MEERA
EU
w/o Drive Unit
720001B0
SN 1 to SN 1416
MEERA US with Drive Unit
720001F2
SN 1 to SN 91
MEERA US w/o Drive Unit
720001F0
SN Ito SN 220
MEERA ST EU
Drive Unit
710001B2
SN 1 to SN 8
MEERA ST
EU
w/o Drive Unit
710001B0
SN 1 to SN 11
MEERA ST US w/o Drive Unit
710001F0
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: +49 7222 932-0
Fax: +49 7222 932-868
www.getinge.com
Gesellschaft mit beschränkter Haftung, Sitz: Rastatt
Registergericht Mannheim HRB 715072
Ust.-IdNr. DE 144021332
Steuer-Nr. 39487/29420
Geschäftsführer:
Dr. Dieter Engel, Dr.
Benno Bröcher
Aufsichtsratsvorsitzender: Frederic Fette
Sicherheitsbeauftragter.medizinprodukte©maquetde
Phone: +49 7222 932-1647
Fax: +49 7222 932-234

Summary

Preventive Corrective Action for OR-Table MEERA

Affected Products

Lists the specific MEERA OR-Table models and their associated article and serial number ranges affected by the safety notice.

Normal Use and Indications

Describes the intended purpose of the mobile OR-Table MEERA for patient positioning during surgical interventions and examinations.

Potential Hazards Identified

Details the risk of electric shock due to exposed electronic components if the IEC socket is pulled out while connected to power.

Operational Precautions

Connecting and Detaching Mains Cable

Provides instructions and visual guidance on safely connecting and disconnecting the mains cable for the OR-Table MEERA.

Corrective Action and Information Dissemination

Corrective Action Plan

Announces the development of a technical solution and the initiation of a field action to update affected OR-Tables.

Information Passing and Acknowledgement

Instructs users to share the notice with relevant personnel and return an acknowledgement form to ensure corrective action effectiveness.

Contact for Further Information

Provides contact details for local Getinge representatives to address any questions or require additional information.

Getinge MEERA 720001B2 Specifications

General

Brand	Getinge
Model	MEERA 720001B2
Category	Medical Equipment
Language	English