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

Model Number	770001B2
Medical Device Problem Codes	Positioning Failure (1158); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 event site name: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our mobile tables - 770001b2 corin w autodrive, sfc, eu.During a shoulder surgery on an anesthetized patient, the operating table became unresponsive to the remote control due to a power failure.Despite plugging the or table into the mains, the table remained inoperative.Emergency procedures were followed to remove and replace the table.The surgery resumed after a 10 minute delay, which did not occur during a critical step of the 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 inability to reposition the patient caused by the operating table's power failure, 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.
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).
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our mobile tables - 770001b2 corin w autodrive, sfc, eu.During a shoulder surgery on an anesthetized patient, the operating table became unresponsive to the remote control due to a power failure.Despite plugging the or table into the mains, the table remained inoperative.Emergency procedures were followed to remove and replace the table.The surgery resumed after a 10 minute delay, which did not occur during a critical step of the 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 inability to reposition the patient caused by the operating table's power failure, 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.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: electrical /electronic property problem|power problem|complete loss of power|4015, activation, positioning or separation problem|positioning problem | positioning failure|1158 corrected h6 medical device ¿ problem code: activation, positioning or separation problem|positioning problem | positioning failure|1158.
Event or Problem Description
Manufacturer's reference number: (b)(4).

• 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: 22068108
• Report Number: 8010652-2025-0000022
• Device Sequence Number: 9338121
• Product Code: FQO
• UDI-Device Identifier: 04046768145207
• UDI-Public: (01)04046768145207(11)250217
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 05/22/2025

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: 770001B2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2025
• Supplement Date Received by Manufacturer: 07/14/2025; 08/22/2025; 03/18/2026
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/07/2025; 09/10/2025; 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2025
• 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