MAUDE Adverse Event Report: MAQUET GMBH BASIS TABLE TOP,INDIVIDUAL CONFIGURATION; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118010A0

Device Problems Circuit Failure (1089); Unintended Movement (3026)

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

Event Type  malfunction  

Event Description

On 22nd february 2024 getinge became aware of an issue with one of our table tops - 118010a0 - basis table top,individual configuration used with 118001c0 - magnus table column, mobile.As it was stated, the operating table suddenly could no longer be operated correctly during the procedure.The operating table moved in the opposite direction than indicated (desired movement: table up, tilting to the right; actual movement: table down, tilting to the left).According to customer allegation, the patient could have inadvertently injured important organs and structures (nerves/vessels) with the surgical instruments during laparoscopy or fallen from the operating table.During service visit on site, the 9704552 control unit for table top was replaced.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the unintended movement of the table top during the procedure, was to reoccur.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1: (b)(6).

• Brand Name: BASIS TABLE TOP,INDIVIDUAL CONFIGURATION
• 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: 18941433
• MDR Text Key: 338889879
• Report Number: 8010652-2024-00044
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118010A0
• Device Catalogue Number: 118010A0
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 118001C0 MAGNUS TABLE COLUMN, MOBILE