MAUDE Adverse Event Report: MAQUET GMBH CORIN MOBILE OPERATING TABLE; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	770001A2
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.Initial reporter: (b)(6).E1 event site name: (b)(6).E1 event site postal code: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our mobile tables - 770001a2 - corin w autodrive, ipc, eu.As it was stated, the operating table stopped in the middle of the spine surgery and no functions were available.At the time of the incident, the table was connected to the mains and the hand control was plugged into the socket.The customer reported that the override panel was not working.As a result, the patient had to be removed with the table still in the spinal position once the procedure was completed.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 override panel, leading to the inability to position the table during surgery, was to reoccur.
Additional Manufacturer Narrative
According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of d4 serial# and d4 unique identifier (udi) # fields is required.This is based on the additional information that has been received.Previous d4 serial#: (b)(6).Corrected d4 serial#: (b)(6).Previous d4 unique identifier (udi) #: (b)(4).Corrected d4 unique identifier (udi) #: (b)(4).
Event or Problem Description
Manufacturer's reference number (b)(4).
Event or Problem Description
Manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.

• Brand Name: CORIN MOBILE OPERATING TABLE
• 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: 21856853
• Report Number: 8010652-2025-0000013
• Device Sequence Number: 12723161
• Product Code: FQO
• UDI-Device Identifier: 04046768145184
• UDI-Public: (01)04046768145184(11)241106
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/17/2025

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
• Operator of Device: Health Professional
• Device Model Number: 770001A2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 08/22/2025; 07/07/2026; 07/07/2026
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/10/2025; 07/07/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2420-2025
• Patient Sequence Number: 1
• Patient Sex: Unknown