MAUDE Adverse Event Report: MAQUET GMBH HYBRID OR TABLE COLUMN, SURFACE-MOUNTED; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001B2

Device Problem Positioning Problem (3009)

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

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 17th february 2023, getinge became aware of an issue with one of our columns - 118001b2 - hybrid or table column, surface-mounted used with siemens angiography system.As it was stated, magnus hybrid system stopped working during a surgery on the anesthetized patient.According to the provided information, the surgery ended when the incident occurred and the patient was transferred to bed with difficulty.There was no injury reported, however, we decided to report the issue in abundance of caution based on potential for serious injury if the situation, namely magnus hybrid system not working during surgery which could potentially lead to delay in treatment and prolonged anesthesia time, was to reoccur.

• Brand Name: HYBRID OR TABLE COLUMN, SURFACE-MOUNTED
• 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: 16559653
• MDR Text Key: 311597551
• Report Number: 8010652-2023-00020
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118001B2
• Device Catalogue Number: 118001B2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1