MAUDE Adverse Event Report: HOLGER ULLRICH YUNO 2 EU WITH AUTODRIVE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 143302B0

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

Patient Problem Electric Shock (2554)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

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.At the time of this report the investigation was still ongoing.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

It was reported that the user received an electric shock when he pulled the charging cable out of the mains connection on the table.A part of the mains connection socket at the table came loose and was pulled out of the anchorage, revealing electric contacts.(b)(4).The customer answered our request concerning required medical intervention as follows: ¿they just went to a&e, no further intervention required.¿.The following injury and treatment was reported by the clinic: ¿first/second fingers and thumb of left hand red and tingling, aching thumb, cold water applied immediately followed by ice cubes.Escorted to a&e by a colleague.12 lead ecg performed, blood samples taken and examined by a&e doctor¿.

Event Description

Manufacturer reference # (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.Maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.Section f - correction- importer changed from maquet medical systems to getinge usa sales, llc.Contact person changed from (b)(4) to (b)(4).

• Brand Name: YUNO 2 EU WITH AUTODRIVE
• 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: 9260229
• MDR Text Key: 173251604
• Report Number: 3013876692-2019-00028
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 143302B0
• Device Catalogue Number: 143302B0
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2020
• Distributor Facility Aware Date: 07/13/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2020
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other