MAUDE Adverse Event Report: MAQUET GMBH MAGNUS OPERATING TABLE SYSTEM; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	118001B2
Medical Device Problem Codes	Positioning Failure (1158); Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.E1 initial reporter: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our columns - 118001b2 ¿ hybrid or table column, surface-mounted used with 118012a0 - multimodality transfer table top eu.As it was stated, after approximately one hour of ongoing neurosurgical surgery, the table reported error 104 and 110 on the ir transmitter when attempting the trendelenburg position, the operating table could only be moved in the antitrendelenburg position.The required position could not be reached via remote hand control, as well as the override panel and other available controllers.The condition lasted for several tens of minutes, then the table started working again for no apparent reason.The surgery was completed.The getinge technician was unable to re-simulate the fault during the test.After the evaluation of the downloaded log files, the errors related to the sensor and column head were found.The position sensors in the operating column and table top were recalibrated, and the device was restored to full working order and returned to service.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
Getinge became aware of an issue with one of our columns - 118001b2 ¿ hybrid or table column, surface-mounted used with 118012a0 - multimodality transfer table top eu.As it was stated, after approximately one hour of ongoing neurosurgical surgery, the table reported error 104 and 110 on the ir transmitter when attempting the trendelenburg position, the operating table could only be moved in the anti-trendelenburg position.The required position could not be reached via remote hand control, as well as the override panel and other available controllers.The condition lasted for several tens of minutes, then the table started working again for no apparent reason.The surgery was completed.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 that was not responding to either the remote control or the override panel, leading to inability to position the patient as required, was to reoccur.Getinge technician inspected the device, but the defect could not be reproduced during the on-site visit.Analysis of the log files indicated that the trend potentiometer in the column was likely causing the issue.Additionally, the height and tilt potentiometers were also reporting fault indications.After consultation with the manufacturer, the position sensors in the column and operating plate were recalibrated in accordance with the manufacturer¿s service manual.Once the adjustment and functional check were carried out the table was released for usage.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.Since the table was unresponsive during the surgery, it was determined that the getinge device failed to perform according to its specified functions.A review of received customer product complaints found no past reports of similar incidents resulting in injury to either a patient or an operator.The subject matter expert (sme) at the manufacturing site was contacted to assess the most probable root cause of the issue.It was stated that reported errors 104 and 110 might be result of the potentiometer wiper being displaced due to a strong mechanical shock or an unintended connection between one of the potentiometer wires and the table cover (a damaged cable sheathing/insulation), combined with electromagnetic interference, e.G., from a high-frequency surgical device.During surgery, the activation of a high-frequency surgical device may corrupt the signal, making the table unresponsive.In the instructions for use (ifu 1180.01 rev 38, page 42) is noted that electromagnetic radiation from electrical devices that are in the vicinity of the product, or directly at/on the product, may affect the functions of the product.However, it was stated that the initial displacement of the potentiometer might have been due to negligence during the manufacturing assembly process or during a post-installation service operation.There was no evidence of improper use or rough handling of the device.In summary and as a result of the performed root cause evaluation, it was concluded that several factors could have contributed to the reported issue occurrence.As none of them could have been confirmed, the root cause of the investigated issue remains impossible to define.We currently do not have any information that would warrant further action regarding device manufacturing or devices on the market.However, as per our complaint handling processes will continue to monitor the customer experiences with the device for any future information.The correction of b5 describe event or problem field deems required.This is based on the internal evaluation and the additional information that has been received.Previous b5 describe event or problem: getinge became aware of an issue with one of our columns - 118001b2 ¿ hybrid or table column, surface-mounted used with 118012a0 - multimodality transfer table top eu.As it was stated, after approximately one hour of ongoing neurosurgical surgery, the table reported error 104 and 110 on the ir transmitter when attempting the trendelenburg position, the operating table could only be moved in the antitrendelenburg position.The required position could not be reached via remote hand control, as well as the override panel and other available controllers.The condition lasted for several tens of minutes, then the table started working again for no apparent reason.The surgery was completed.The getinge technician was unable to re-simulate the fault during the test.After the evaluation of the downloaded log files, the errors related to the sensor and column head were found.The position sensors in the operating column and table top were recalibrated, and the device was restored to full working order and returned to service.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.Corrected b5 describe event or problem: getinge became aware of an issue with one of our columns - 118001b2 ¿ hybrid or table column, surface-mounted used with 118012a0 - multimodality transfer tabletop eu.As it was stated, after approximately one hour of ongoing neurosurgical surgery, the table reported error 104 and 110 on the ir transmitter when attempting the trendelenburg position, the operating table could only be moved in the anti-trendelenburg position.The required position could not be reached via remote hand control, as well as the override panel and other available controllers.The condition lasted for several tens of minutes, then the table started working again for no apparent reason.The surgery was completed.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 that was not responding to either the remote control or the override panel, leading to inability to position the patient as required, was to reoccur.
Event or Problem Description
Getinge became aware of an issue with one of our columns - 118001b2 ¿ hybrid or table column, surface-mounted used with 118012a0 - multimodality transfer table top eu.As it was stated, after approximately one hour of ongoing neurosurgical surgery, the table reported error 104 and 110 on the ir transmitter when attempting the trendelenburg position, the operating table could only be moved in the anti-trendelenburg position.The required position could not be reached via remote hand control, as well as the override panel and other available controllers.The condition lasted for several tens of minutes, then the table started working again for no apparent reason.The surgery was completed.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 that was not responding to either the remote control or the override panel, leading to inability to position the patient as required, was to reoccur.

• Brand Name: MAGNUS OPERATING TABLE SYSTEM
• 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: 22267467
• Report Number: 8010652-2025-0000028
• Device Sequence Number: 7047689
• Product Code: FQO
• UDI-Device Identifier: 04046768088351
• UDI-Public: (01)04046768088351(11)240301
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 118001B2
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 118012A0 MULTIMODALITY TRANSFER TABLE TOP.
• Patient Sex: Unknown