MAUDE Adverse Event Report: HOLGER ULLRICH MEERA EU WITH AUTO DRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number MEERA EU WITH AUTO DRIVE

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

Patient Problem Electric Shock (2554)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

At the date of this report the investigation is still ongoing.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.As soon as the investigation is finished the report will be updated and a follow-up/final report will be provided to fda.

Event Description

The following was reported: the mains connector at the table came apart and a member of staff got an electrical shock from it.No medical treatment was reported.The person who got the electrical shock is said to be fine.Manufacturer reference number: (b)(4).

Manufacturer Narrative

The affected socket was returned for further investigation.This investigation revealed that the socket was pulled apart.The supplier of this cold device plug confirmed that this issue occurred due to a manufacturing failure at the sub-suppliers site.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.For this kind of malfunction the field safety corrective action (fsca) "capa 2018-025" was started.Within the scope of this fsca a field safety notice (fsn) was sent to all customers.The customer was informed, but the affected table not yet updated with a technical solution, that will prevent this issue.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: MEERA EU WITH AUTO DRIVE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 9277285
• MDR Text Key: 190778646
• Report Number: 8010652-2019-00026
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

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: MEERA EU WITH AUTO DRIVE
• Device Catalogue Number: 720001B2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/16/2019
• Initial Date FDA Received: 11/05/2019
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other