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

Model Number	115030D0
Medical Device Problem Codes	Difficult to Open or Close (2921); Unintended Movement (3026)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/28/2025
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.E1 event site postal code: (b)(6).
Event or Problem Description
Getinge became aware of an issue with one of our devices - 115030d0 - modular universal table top, using with 115031d0 - standard back plate and 113064g0 - head rest.During the preparation for spinal fixation surgery the patient was transferred from the stretcher to the operating table in a prone position.The patient's body was shifted toward the head side to adjust the position.At this moment, the clamp of the operating table's chest section suddenly broke and fell, despite being locked.This caused the patient to suddenly fall toward the head side of the table.The medical team quickly intervened and supported the patient, preventing any head injury.Since the breathing circuit had not yet been connected, there was no accidental removal of the intubation tube.The patient was then transferred back to the stretcher to ensure safety.As vital signs remained stable throughout the incident, the surgery was performed after the table was replaced and anesthesia was administered.Due to the fall, the patient suffered a minor 1 cm abrasion on the right arm.No other injuries or abnormalities were observed during a full-body visual inspection, and post-operative x-rays confirmed no fractures or other complications.We decided to report the issue based on the potential for serious injury if the situation, namely the fast unintended movement which could result in the patient¿s fall, was to reoccur.
Event or Problem Description
Getinge became aware of an issue with one of our devices - 115030d0 - modular universal table top, used with 115031d0 - standard back plate and 113064g0 - head rest.During the preparation for spinal fixation surgery the patient was transferred from the stretcher to the operating table in a prone position.The patient's body was shifted toward the head side to adjust the position.At this moment, the clamp of the operating table's chest section suddenly broke and fell, despite being locked.This caused the patient to suddenly fall toward the head side of the table.The medical team quickly intervened and supported the patient, preventing any head injury.Since the breathing circuit had not yet been connected, there was no accidental removal of the intubation tube.The patient was then transferred back to the stretcher to ensure safety.As vital signs remained stable throughout the incident, the surgery was performed after the table was replaced and anesthesia was administered.Due to the fall, the patient suffered a minor 1 cm abrasion on the right arm.No other injuries or abnormalities were observed during a full-body visual inspection, and post-operative x-rays confirmed no fractures or other complications.We decided to report the issue based on the potential for serious injury if the situation, namely the sudden unintended movement which could result in the patient¿s fall, was to reoccur.
Additional Manufacturer Narrative
Getinge became aware of an issue with one of our devices - 115030d0 - modular universal table top, used with 115031d0 - standard back plate and 113064g0 - head rest.During the preparation for spinal fixation surgery the patient was transferred from the stretcher to the operating table in a prone position.The patient's body was shifted toward the head side to adjust the position.At this moment, the clamp of the operating table's chest section suddenly broke and fell, despite being locked.This caused the patient to suddenly fall toward the head side of the table.The medical team quickly intervened and supported the patient, preventing any head injury.Since the breathing circuit had not yet been connected, there was no accidental removal of the intubation tube.The patient was then transferred back to the stretcher to ensure safety.As vital signs remained stable throughout the incident, the surgery was performed after the table was replaced and anesthesia was administered.Due to the fall, the patient suffered a minor 1 cm abrasion on the right arm.No other injuries or abnormalities were observed during a full-body visual inspection, and post-operative x-rays confirmed no fractures or other complications.We decided to report the issue based on the potential for serious injury if the situation, namely the sudden unintended movement which could result in the patient¿s fall, was to reoccur.A technical inspection of the affected device was conducted, and a malfunction of table top¿s eccentric lever mechanism was found.The affected rubber buffer and washer were replaced (part no.90302784 and 1150899).Following the functional testing, the device was cleared for use and returned to service.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 operating table malfunction was found, 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.A rubber buffer (part no.90302784) replaced by the technician is included in the standard 4-year maintenance kit.According to the maintenance manual (tw 1150.30xx en04, page 3), technicians are required to check the locking force of the eccentric levers and replace any worn-out parts.The user manual (ifu 1150.30 en 18, page 81) further specifies that to maintain proper functionality of the back segment, certain components (part numbers: 50061934, 90302784, 40042454, and 68103584) must be replaced every 4 years as part of maintenance kit 31157463.The customer holds a maintenance contract with getinge, and the device underwent its most recent maintenance in november 2024, during which no malfunctions or issues were reported.According to the sales and service unit, the maintenance kit 31157463 has not been replaced during the november maintenance.Furthermore, it was confirmed that available records indicate these components have never been replaced since the product's initial installation.In summary, based on the root cause evaluation, it can be concluded that the reported issue, namely the sudden unintended movement which could result in the patient¿s fall, was a result of improper maintenance and could be related to a service-business issue.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.

• 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: 21332018
• Report Number: 8010652-2025-0000005
• Device Sequence Number: 18174945
• Product Code: FQO
• UDI-Device Identifier: 04046768003354
• UDI-Public: (01)04046768003354
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 115030D0
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2003
• 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: 115031D0 STANDARD BACK PLATE, 113064G0 HEAD REST.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown