MAUDE Adverse Event Report: MAQUET GMBH CORIN W AUTODRIVE, IPC, EU; 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	05/20/2025
Type of Reportable Event	Malfunction
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 working and was not responding to the ir and cable remote controls as well as the override panel at the beginning of the colectomy surgery.The table also did not work when connected to the mains.The patient had to be moved to another operating table, which resulted in prolonged anesthesia time.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 override panel, leading to the inability to position the table during surgery, was to reoccur.
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
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.E1 event site name: (b)(6).Initial reporter: getinge application engineer.
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.
Event or Problem Description
Manufacturer's reference number (b)(4).

• Brand Name: CORIN W AUTODRIVE, IPC, EU
• 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: 22157422
• Report Number: 8010652-2025-0000026
• Device Sequence Number: 8842232
• Product Code: FQO
• UDI-Device Identifier: 04046768145184
• UDI-Public: (01)04046768145184(11)241014
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 08/22/2025; 05/22/2026
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/10/2025; 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• 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 Age: 35 YR
• Patient Sex: Male
• Patient Weight: 78 KG