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

Model Number	770001A2
Medical Device Problem Codes	Positioning Failure (1158); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 in the middle of the surgery.Later on, it was confirmed that the override panel did not work during the incident.During a service visit on site, the controller unit for table top was found to be defective and was replaced.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.E1 event site name: (b)(6).E1 event site postal code: (b)(6).
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).
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).
Event or Problem Description
Getinge became aware of an issue with one of our device - 770001a2 - corin w autodrive, ipc, eu.As it was stated, the operating table stopped in the middle of the surgery.Later on, it was confirmed that the override panel did not work during the incident.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
Getinge became aware of an issue with one of our device - 770001a2 - corin w autodrive, ipc, eu.As it was stated, the operating table stopped in the middle of the surgery.Later on, it was confirmed that the override panel did not work during the incident.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.Based on the investigation conducted, it was concluded that at the time of the event, the device was actively being used for the patient¿s treatment and was therefore directly involved in the reported incident.As the operating table malfunctioned, it was considered that the getinge device failed to meet its specifications.A review of received customer product complaints found no past reports of similar incidents resulting in injury to either a patient or an operator.A root cause evaluation was conducted and revealed that, under certain conditions, the corin operating table (770001xy) may become unresponsive to all commands.In such cases, it is impossible to initiate any movement of the table using either the universal remote control or the override panel.The manufacturer has initiated the capa: 2025-013 and related fsca (field safety corrective action).Software updates are initiated to address the described issue and improve the system robustness and stability.In summary and as a result of the root cause evaluation, it can be concluded that the reported issue, no function of the operating table, neither with override, was caused by the design of the device.E1 initial reporter: (b)(6).The correction of h6 medical device ¿ problem code field deems required.This is based on the internal evaluation and the additional information that has been received.Previous h6 medical device ¿ problem code: activation, positioning or separation problem|positioning, problem|positioning failure|1158, electrical /electronic property problem|interrogation problem|failure to interrogate|1332 corrected h6 medical device ¿ problem code: activation, positioning or separation problem|positioning, problem|positioning failure|1158.

• 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: holger ullrich ; kehler strasse 31; rastatt ; GM
• MDR Report Key: 22077628
• Report Number: 8010652-2025-0000024
• Device Sequence Number: 9394320
• 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: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/23/2025

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: 770001A2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 08/22/2025; 02/11/2026
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/10/2025; 02/11/2026
• 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