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

Model Number	118001B4
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of our table 118001b4: hybrid or table column, surface-mounted.As it was stated, during the emergency surgery involving a patient with a ruptured intracranial aneurysm, the dsa reported an error, the operating table moved slowly, and 3d imaging was impossible.With remote guidance from the manufacturer's engineer, the error was temporarily resolved, but the same error reappeared five minutes later.After the error occurred, the equipment moved slowly, making 3d scanning unusable and preventing the provision of real-time 3d path guidance, a recurring cycle.The surgery was finished.There was no injury reported.However, we decided to report the issue based on the potential for serious injury if the situation, namely delay in start of treatment in a critical step of the treatment, was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1.Event site postal code: (b)(6).E1.Event site name: (b)(6) hospital.E1.Event site address: (b)(6).

• 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: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 24530352
• Report Number: 8010652-2026-0000009
• Device Sequence Number: 21418400
• Product Code: FQO
• UDI-Device Identifier: 04046768124752
• UDI-Public: (01)04046768124752(11)220203
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 118001B4
• Device Catalogue Number: 118001B4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown