MAUDE Adverse Event Report: KEHLER STRASSE 31 MAQUET MAGNUS; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 1180.01C0

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

A maquet field service technician (fst) visited the hospital and checked the table.The fst was able to reproduce the described failure.Root cause was a defective control unit of the operating room table column.He replaced the control unit and tested the functions and all movements of the operating room table system.Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

The hospital reported that during a surgical procedure, the operating room table could no longer be moved and a change to the position of the table was not possible either.The display of the hand control showed error #102.The patient had to be manually taken to another table so that the surgical procedure could be proceed.No injuries reported to maquet.(b)(4).

• Brand Name: MAQUET MAGNUS
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): KEHLER STRASSE 31; rastatt 76437 ; GM 76437
• Manufacturer (Section G): MR. BERND RAKO; maquet gmbh; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet gmbh; kehler strasse 31; rastatt 76437
• MDR Report Key: 5368357
• MDR Text Key: 36463951
• Report Number: 8010652-2016-00001
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1180.01C0
• Device Catalogue Number: 1180.01C0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2015
• Date Device Manufactured: 11/01/2006
• 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