MAUDE Adverse Event Report: MAQUET GMBH MAGNUS TABLE COLUMN FOR BUILT-IN PLATE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001A0

Device Problem Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.

Event Description

On (b)(3) 2023 getinge became aware of an issue with one of our table columns ¿118001a0 - magnus table column for built-in plate.As it was stated, during the surgery of the anesthetized patient, the longitudinal displacement connection with the table top was lost.The staff tried to move the table to the desired position what resulted in delay in treatment (around 2 minutes).The surgery was performed under difficult conditions.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.

• Brand Name: MAGNUS TABLE COLUMN FOR BUILT-IN PLATE
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer (Section G): MAQUET GMBH; kehler strasse 31; rastatt ; GM
• Manufacturer Contact: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 18225426
• MDR Text Key: 330457504
• Report Number: 8010652-2023-00128
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118001A0
• Device Catalogue Number: 118001A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1