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

Model Number	118001C0
Medical Device Problem Codes	Positioning Failure (1158); Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.The full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.
Event or Problem Description
On 12th september 2024, getinge became aware of an issue with one of our columns - 118001c0 - magnus table column, mobile.As it was stated, the column broke down during emergency laparotomy on the anesthetized patient.The tabletop was in inclined position and the patient was non-transferable.According to provided information, the table could not be operated via remote control nor override panel and there were no indicator lights on the base or on the control panel when the charger was plugged in.Following removal and replacement of the main fuse during the procedure, the column could be woken up.The issue resulted in a 30-minute delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the operating table not responding to remote control or override panel leading to inability to position the table and procedural delay during emergency procedure, were to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our columns - 118001c0 - magnus table column, mobile.As it was stated, the column broke down during emergency laparotomy on the anesthetized patient.The table top was in an inclined position and the patient was non-transferable.According to the provided information, the table could not be operated using the remote control or override panel and there were no indicator lights on the base or on the control panel when the charger was plugged in.Following removal and replacement of the main fuse during the procedure, the column could be woken up.The issue resulted in a 30-minute delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the operating table not responding to the remote control or override panel leading to the inability to position the table and procedural delay during the emergency surgery, were to reoccur.The intervention was canceled.The column was removed from use and dismantled.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As the malfunction occurred, it was considered that the getinge device failed to meet its specifications.A review of the received customer product complaints revealed that there were no injuries to a user nor to a patient or operator when this particular incident occurred.The subject matter expert (sme) at the manufacturing site was contacted to assess the most probable root cause of the issue.According to the sme¿s evaluation, there was a general electrical defect.The affected column was manufactured in 2010 and has been in use for almost 14 years.Therefore, it can be suspected that the issue investigated herein could be related to the age of the device.However, since the intervention was cancelled and the column was dismantled making further analysis impossible, it was determined that the exact cause of the described event could not be identified.In summary and as a result of the performed root cause evaluation, it was concluded that the investigated issue, namely the operating table not responding to the remote control or override panel leading to the inability to position the table and procedural delay during the emergency surgery, was 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, h3a device evaluated by manufacturer and h8 usage of the device fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 12th september 2024, getinge became aware of an issue with one of our columns - 118001c0 - magnus table column, mobile.As it was stated, the column broke down during emergency laparotomy on the anesthetized patient.The table top was in inclined position and the patient was non-transferable.According to provided information, the table could not be operated via remote control nor override panel and there were no indicator lights on the base or on the control panel when the charger was plugged in.Following removal and replacement of the main fuse during the procedure, the column could be woken up.The issue resulted in a 30-minute delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the operating table not responding to remote control or override panel leading to inability to position the table and procedural delay during emergency procedure, were to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our columns - 118001c0 - magnus table column, mobile.As it was stated, the column broke down during emergency laparotomy on the anesthetized patient.The table top was in an inclined position and the patient was non-transferable.According to the provided information, the table could not be operated using the remote control or override panel and there were no indicator lights on the base or on the control panel when the charger was plugged in.Following removal and replacement of the main fuse during the procedure, the column could be woken up.The issue resulted in a 30-minute delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the operating table not responding to the remote control or override panel leading to the inability to position the table and procedural delay during the emergency surgery, were to reoccur.Previous h3a device evaluated by manufacturer: yes.Corrected h3a device evaluated by manufacturer: no.Previous h8 usage of the device: initial use.Corrected h8 usage of the device: reuse.
Event or Problem Description
Getinge became aware of an issue with one of our columns - 118001c0 - magnus table column, mobile.As it was stated, the column broke down during emergency laparotomy on the anesthetized patient.The table top was in an inclined position and the patient was non-transferable.According to the provided information, the table could not be operated using the remote control or override panel and there were no indicator lights on the base or on the control panel when the charger was plugged in.Following removal and replacement of the main fuse during the procedure, the column could be woken up.The issue resulted in a 30-minute delay.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situations, namely the operating table not responding to the remote control or override panel leading to the inability to position the table and procedural delay during the emergency surgery, were 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: 20308980
• Report Number: 8010652-2024-0000088
• Device Sequence Number: 8759323
• Product Code: FQO
• UDI-Device Identifier: 04046768031555
• UDI-Public: (01)04046768031555
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 118001C0
• 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: 09/12/2024
• Supplement Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/25/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown