MAUDE Adverse Event Report: MAQUET GMBH STATIONARY TRANSFORMER UNIT; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	115080A0
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Getinge became aware of an issue with one of our devices 115080a0 - stationary transformer used with 118001b2 - hybrid or table column, surface-mounted.According to the user statement, the or table failed to move during the procedure.Neither the remote control nor the control panel could operate it during a neurosurgical angiography procedure.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.The full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.Event site name: (b)(6) hospital.E1 event site postal code: (b)(6).

• Brand Name: STATIONARY TRANSFORMER UNIT
• 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: 24187547
• Report Number: 8010652-2026-0000002
• Device Sequence Number: 18604526
• Product Code: FQO
• UDI-Device Identifier: 04046768080195
• UDI-Public: (01)04046768080195(11)230116
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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
• Operator of Device: Health Professional
• Device Model Number: 115080A0
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 118001B2 - HYBRID OR TABLE COLUMN, SURFACE-MOUNTED.
• Patient Age: 55 YR
• Patient Sex: Female