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

Model Number	115030B0
Medical Device Problem Codes	Difficult to Open or Close (2921); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
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.E1a initial reporter: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our table tops - 115030b0 - modular universal table top.As it was stated, the upper back part of the operating board released upon loading with an anesthetized patient with a higher weight resulting in change in the patient's position during unspecified leg/knee surgery.The staff was able to capture and stabilize the loose back part with the patient.The incident resulted in a non-significant delay.According to provided information, at the time of incident, the patient was secured with belts.Following service visit on site, it was confirmed that the probable cause was issue at locking mechanism and the affected parts (1150449 washer, 90302784 rubber buffer and 40042154 toothed disc) have been replaced.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely unintended movement of the table during surgery creating a risk of nerve overstretching, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our table tops - 115030b0 - modular universal table top.As it was stated, the upper back part of the operating board released upon loading with an anesthetized patient with a higher weight resulting in change in the patient's position during unspecified leg/knee surgery.The staff was able to capture and stabilize the loose back part with the patient.The incident resulted in a non-significant delay.According to provided information, at the time of incident, the patient was secured with belts.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely unintended movement of the table during surgery creating a risk of nerve overstretching, was to reoccur.Following service visit on site, it was confirmed that the probable cause was issue at locking mechanism and the affected parts (1150449 washer, 90302784 rubber buffer and 40042154 toothed disc) have been replaced.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 issue occurred, 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.The affected tabletop was manufactured in september 2009.A review of the customer product complaints database showed no prior complaints registered for this specific device.The customer holds a maintenance contract with getinge.The affected toothed disc (part no.40042154) is a component of maintenance kit 31157463, which should be replaced every four years.According to the technician¿s report, the last replacement of this part occurred in october 2021.A pre-use check was conducted before the surgery, during which no damage was detected or reported.While normal wear was observed (consistent with over three years of use), there was no evidence of improper use.The affected toothed disc has since been scrapped, making a detailed analysis impossible.In summary and as a result of the root cause evaluation, it can be concluded that the reported issue, namely the unintended movement of the headboard with a patient on the table creating a risk of neck overstretching, 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 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 table tops - 115030b0 - modular universal table top.As it was stated, the upper back part of the operating board released upon loading with an anesthetized patient with a higher weight resulting in change in the patient's position during unspecified leg/knee surgery.The staff was able to capture and stabilize the loose back part with the patient.The incident resulted in a non-significant delay.According to provided information, at the time of incident, the patient was secured with belts.Following service visit on site, it was confirmed that the probable cause was issue at locking mechanism and the affected parts (1150449 washer, 90302784 rubber buffer and 40042154 toothed disc) have been replaced.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely unintended movement of the table during surgery creating a risk of nerve overstretching, was to reoccur.Corrected b5 describe event or problem: getinge became aware of an issue with one of our table tops - 115030b0 - modular universal table top.As it was stated, the upper back part of the operating board released upon loading with an anesthetized patient with a higher weight resulting in change in the patient's position during unspecified leg/knee surgery.The staff was able to capture and stabilize the loose back part with the patient.The incident resulted in a non-significant delay.According to provided information, at the time of incident, the patient was secured with belts.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely unintended movement of the table during surgery creating a risk of nerve overstretching, was to reoccur.
Event or Problem Description
Getinge became aware of an issue with one of our table tops - 115030b0 - modular universal table top.As it was stated, the upper back part of the operating board released upon loading with an anesthetized patient with a higher weight resulting in change in the patient's position during unspecified leg/knee surgery.The staff was able to capture and stabilize the loose back part with the patient.The incident resulted in a non-significant delay.According to provided information, at the time of incident, the patient was secured with belts.There was no injury reported, however, we decided to report the issue based on the potential for serious injury if the situation, namely unintended movement of the table during surgery creating a risk of nerve overstretching, was to reoccur.

• Brand Name: MODULAR UNIVERSAL 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: 20704044
• Report Number: 8010652-2024-0000093
• Device Sequence Number: 15928816
• Product Code: FQO
• UDI-Device Identifier: 04046768003347
• UDI-Public: (01)04046768003347
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2024

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: 115030B0
• 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: 11/01/2024
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown