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

Model Number	118001A0
Medical Device Problem Codes	Circuit Failure (1089); Positioning Failure (1158); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
Event or Problem Description
On (b)(3) 2023 getinge became aware of an issue with one of our table columns ¿118001a0 - magnus table column for built-in plate.As it was stated, during the surgery of the anesthetized patient, the longitudinal displacement connection with the table top was lost.The staff tried to move the table to the desired position what resulted in delay in treatment (around 2 minutes).The surgery was performed under difficult conditions.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our table columns ¿118001a0 - magnus table column for built-in plate.As it was stated, during the surgery of the anesthetized patient, the longitudinal displacement connection with the table top was lost.The staff tried to move the table to the desired position what resulted in delay in treatment (around 2 minutes).The surgery was performed under difficult conditions.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely inability to position the table during procedure, was to reoccur.Based on the investigation, it was concluded that at the time of the incident, the devices were being used for the patient's treatment and therefore were directly involved in the reported event.Since the operating table was unable to position the table during the procedure, it was determined that the getinge devices failed to perform according to their specified functions.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 error occurred during an operation when the tilt adjustment of the operating table failed while trying to reposition the patient, which was necessary for the procedure.Although the situation was not a medical emergency and the patient was under anesthesia, the malfunction caused a brief delay of around two minutes as the surgical team attempted to adjust the table.When the tilt adjustment could not be fixed, the surgery proceeded under difficult conditions due to the inability to achieve the optimal positioning.After the operation, the operating room was closed for safety reasons because trendelenburg positioning - a critical position for certain surgeries - would not be possible to set.The affected device was evaluated by a getinge technician, who confirmed the malfunction of the table.Error codes 22/8, 35/8, and 138/7 were identified.A detailed troubleshooting was performed, and various components were replaced and tested, including the hydraulic unit (31150329), tilt potentiometer (31154789), and contact module (9704653).Despite these replacements, the error persisted, and the reason of the malfunction remained unidentified.As a result, the column was sent to the factory for further examination, and a replacement column was installed in the meantime.Upon inspection at the manufacturer's site, a broken cable was found in the wiring harness (2007861) of the operating table column head.This damaged cable was the cause of the malfunction.The faulty part was repaired, and the device was returned to the customer.The affected devices were manufactured in december 2016 and had been in use for 7 years at the time of the event.A review of the customer product complaints database revealed no prior complaints related to the reported issues for this device.According to the manufacturer's evaluation, wear on the affected wiring harness may have contributed to its damage, as was it pointed by the technician.In summary, despite our best efforts to gather information during the root cause evaluation, the exact cause of the failure remains undetermined.Since we could not identify the specific reason for the issue, the root cause remains unknown and 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 full unique identifier (udi) # information is not available since the device was manufactured before 09/24/2022.The correction of b5 describe event or problem, d1 brand name, d4 catalog #, d4 serial #, d4 unique identifier (udi) #, h3a device evaluated by manufacturer, h3b device not eval provide code, h3c if other provide code ¿ explain, h4 device manufacture date and h6 medical device ¿ problem code fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 20th november 2023 getinge became aware of an issue with one of our table columns ¿118001a0 - magnus table column for built-in plate.As it was stated, during the surgery of the anesthetized patient, the longitudinal displacement connection with the table top was lost.The staff tried to move the table to the desired position what resulted in delay in treatment (around 2 minutes).The surgery was performed under difficult conditions.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely the delay in surgery resulting in prolonged anesthesia time, was to reoccur.Corrected b5 describe event or problem: on 20th november 2023 getinge became aware of an issue with one of our table columns ¿118001a0 - magnus table column for built-in plate.As it was stated, during the surgery of the anesthetized patient, the longitudinal displacement connection with the table top was lost.The staff tried to move the table to the desired position what resulted in delay in treatment (around 2 minutes).The surgery was performed under difficult conditions.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely inability to position the table during procedure, was to reoccur.Previous d1 brand name: magnus table column for built-in plate.Corrected d1 brand name: magnus operating table system.Previous d4 catalog #: 118001a0.Corrected d4 catalog #: n/a.Previous d4 serial #: (b)(6).Corrected d4 serial #: (b)(6).Previous d4 unique identifier (udi) #: n/a.Corrected d4 unique identifier (udi) #: (b)(4).Previous h3a device evaluated by manufacturer: no.Corrected h3a device evaluated by manufacturer: yes.Previous h3b device not eval provide code: other.Corrected h3b device not eval provide code: n/a.Previous h3c if other provide code - explain: device not returned to manufacturer.Corrected h3c if other provide code - explain: n/a.Previous h4 device manufacture date: 12/01/2016.Corrected h4 device manufacture date: 11/24/2016.Previous h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem||3009.Corrected h6 medical device ¿ problem code: activation, positioning or separationproblem|positioning problem|positioning failure|1158 electrical /electronic property problem|circuit failure||1089.
Event or Problem Description
On (b)(6) 2023 getinge became aware of an issue with one of our table columns ¿118001a0 - magnus table column for built-in plate.As it was stated, during the surgery of the anesthetized patient, the longitudinal displacement connection with the table top was lost.The staff tried to move the table to the desired position what resulted in delay in treatment (around 2 minutes).The surgery was performed under difficult conditions.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely inability to position the table during procedure, 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: 18225426
• Report Number: 8010652-2023-00128
• Device Sequence Number: 17487867
• Product Code: FQO
• UDI-Device Identifier: 04046768031500
• UDI-Public: (01)04046768031500
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 118001A0
• Device Catalogue Number: 118001A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown