MAUDE Adverse Event Report: MAQUET GMBH BASIC TABLE TOP; TABLE, OPERATING-ROOM, AC-POWERED

Model Number	118010A0
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	05/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided following the conclusion of the investigation.
Event or Problem Description
On 13th may 2024, getinge became aware of an issue with one of our columns - 118001a0 - magnus table column for built-in plate.As it was stated, the error 10/105 was displayed and column could not be operated with the remote control or override panel during surgery on the anesthetized patient.The issue did not lead to a delay.The error 10/105 could be related to the issue with sensor.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 remote control or override panel leading to inability to position the table during procedure, was to reoccur.
Event or Problem Description
On 13th may 2024, getinge became aware of an issue with one of our tabletops - 118010a0 - basis tabletop, individual configuration used with 118001a0 - magnus table column for built-in plate.As stated, error 10/105 was displayed, and the operating table could not be controlled via the remote control or override panel during surgery on an anesthetized patient.This issue did not cause any delays.Error 10/105 may be related to a sensor problem.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 procedure, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our table tops - 118010a0 - basis table top, individual configuration used with 118001a0 - magnus table column for built-in plate.As stated, error 10/105 was displayed, and the operating table could not be controlled via the remote control or override panel during surgery on an anesthetized patient.This issue did not cause any delays.Error 10/105 may be related to a sensor problem.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 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 became unresponsive to both the remote control and the override panel, it was determined that the getinge devices failed to perform according to their specified functions.Comparing the number of complained devices to the number of 1180.10 table tops and columns 1180 placed on the market we can conclude that the failure ratio is (b)(4) for the issue investigated herein.The affected device was evaluated by a getinge technician, who confirmed the malfunction of the table.Error 10/105, related to master/slave positional control, may have been due to a sensor issue, although no sensor values were found outside the defined range.Additionally, the technician confirmed that no log files were available for further evaluation as they had already been deleted from his pc.The technician adjusted and recalibrated the operating table in service mode, following service instructions.Upon inspection by a getinge technician, it was found that the table top supports were warped, likely due to external impact.The warped supports were straightened on-site since no permanently defective parts were identified.The damage to the table top appeared unrelated to the original error (10/105) and was likely discovered during the technician's visit.After a comprehensive diagnosis of these issues, the technician successfully carried out the necessary repairs, ensuring the devices were restored to full working order and returned to service.According to the maintenance manual (1180_10x0_maintenance_manual rev 07, page 59), adjustment of the table top and reading of the error log is an integral part of the maintenance procedure.The maintenance was carried out 2 months before the event (march 2024).Therefore, insufficient or untimely maintenance can be excluded as a cause.The affected devices were manufactured in november 2009 and had been in use for over 14 years at the time of the event.A review of the customer product complaints database revealed no previous complaints related to the reported issues for those devices.According to the risk management plan risk management plan _ lagerflaeche cepg.0118, page 3), the expected service life of the table top is 10 years.The device's age likely contributed to the issue.In summary and as a result of the performed root cause evaluation, it was concluded that based on available information the most probable root cause of the reported issue, namely the operating table not responding to the remote control or override panel leading to the inability to position the table during procedure, is related to a misadjustment that occurs more frequently in products older than their expected service life.Therefore, we assign the root cause to expected wear and tear.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, d1 brand name, d4 version or model#, d4 catalog#, d4 serial#, d4 unique identifier (udi)#, h4 device manufacture date fields deems required.This is based on the internal evaluation.Previous b5 describe event or problem: on 13th may 2024, getinge became aware of an issue with one of our columns - 118001a0 - magnus table column for built-in plate.As it was stated, the error 10/105 was displayed and column could not be operated with the remote control or override panel during surgery on the anesthetized patient.The issue did not lead to a delay.The error 10/105 could be related to the issue with sensor.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 remote control or override panel leading to inability to position the table during procedure, was to reoccur.Corrected b5 describe event or problem: on 13th may 2024, getinge became aware of an issue with one of our table tops - 118010a0 - basis table top, individual configuration used with 118001a0 - magnus table column for built-in plate.As stated, error 10/105 was displayed, and the operating table could not be controlled via the remote control or override panel during surgery on an anesthetized patient.This issue did not cause any delays.Error 10/105 may be related to a sensor problem.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 procedure, was to reoccur.Previous d1 brand name: magnus table column for built-in plate.Corrected d1 brand name: basic tabletop.Previous d4 version or model#: 118001a0.Corrected d4 version or model#: 118010a0.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 h4 device manufacture date: 11/01/2009.Corrected h4 device manufacture date: 11/10/2009.

• Brand Name: BASIC TABLE TOP
• 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: 19402906
• Report Number: 8010652-2024-00065
• Device Sequence Number: 7762816
• Product Code: FQO
• UDI-Device Identifier: 04046768031593
• UDI-Public: (01)04046768031593
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/28/2024

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
• Device Model Number: 118010A0
• 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: 05/13/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2009
• 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: 118001A0 MAGNUS TABLE COLUMN FOR BUILT-IN PLATE.
• Patient Sex: Unknown