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

Model Number 720001B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.Just a combination of not correct assembled cold-device-plug and not following the ifu can lead to the described failure.The affected table was repaired by (b)(4) service technician.(b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

It was reported that at least two people 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 operating room table.The mains cable was plugged in at the mains socket in the wall.The customer told us that the nurse touched two people with the cable.These received an electric shock.No medical intervention or serious injury was reported.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: 8361534
• MDR Text Key: 137521746
• Report Number: 8010652-2019-00008
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 720001B0
• Device Catalogue Number: 720001B0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2017
• 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