MAUDE Adverse Event Report: MAQUET GMBH MAGNUS OPERATING TABLE SYSTEM; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	118001A0
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of our columns ¿ 118001a0 ¿ magnus table column for built-in plate.As stated, during a surgical procedure on a patient in critical condition, the operating table column became inoperative - both the control panel and the remote control were non-functional.The malfunction resulted in the transfer of the patient to another operating room.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the operating table not responding to the remote control or the override panel, leading to inability to position the patient as required, was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 event site name: (b)(6).The full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.

• Brand Name: MAGNUS OPERATING TABLE SYSTEM
• Common Device Name: 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: diana gutekunst ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 23617776
• Report Number: 8010652-2025-0000040
• Device Sequence Number: 21095244
• Product Code: FQO
• UDI-Device Identifier: 04046768031500
• UDI-Public: (01)04046768031500
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 118001A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown