MAUDE Adverse Event Report: HOLGER ULLRICH MEERA EU WITHOUT AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 720001B2

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Electric Shock (2554)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

The failure described by the customer could be reproduced at maquet.A supplier complaint revealed a problem with the offset of the plastic socket.It may be possible that in some cases the plastic socket is not pressed deep enough into the housing so that not both pins secure the plastic socket in the housing.Further tests by the supplier showed that when just one pin is fixed the connection meets its specification.In the instructions for use (ifu) the connection to mains supply and the detachment of the mains cable is described.For detaching, it is stated: ¿detach the plug at the main socket.Detach the mains cable from the mobile operating table.¿ this means the customer first has to disconnect the cable from the mains socked (from the wall) and then pull the plug out of the table.The user confirmed that the table was not connected from the main socket first.Just a combination of not correct assembled cold-device-plug and not following the ifu can lead to the described failure.Field safety corrective action (fsca) capa (b)(4) was started for this issue.As part of this fsca a field safety notice (fsn) was sent to the customer.In this fsn the customer of the table was informed that the ifu has to be followed.The customer has confirmed that the fsn was read, understood and that all users within the facility were informed as well as the note concerning the disconnection order would be followed.Further, in the fsn it is stated that a field action was initiated to modify the affected sockets.This modification was not yet performed for the affected table, when the incident occurred.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

It was reported that a nurse received an electric shock by touching a pulled out socket.A socket was pulled out of the table when the user tried to disconnect the mains cable from the or table.The mains cable was plugged in at the mains socket in the wall.Manufacturer reference # (b)(4).

• Brand Name: MEERA EU WITHOUT AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer (Section G): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31,; rastatt 76437
• MDR Report Key: 8757721
• MDR Text Key: 150149828
• Report Number: 8010652-2019-00020
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001B2
• Device Catalogue Number: 720001B2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other