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

Model Number 116010A0

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Pain (1994)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, getinge became aware of an incident with one of our table tops ¿ 116010a0 - universal table top, ipc, eu used with 113070ac maquetmatic during surgery.As it was stated, the patient was operated in gynecological position with legs in knee crutches.The table top was in anti-trendelenburg position of maximum 5 degress.At the end of surgical procedure, the legs were lowered resulting in the anesthetized patient sliding down on the table top between central part and knee crutches.The staff supported the patient and pulled her up on the table top.The procedure was delayed by approximately 15 minutes.The staff member reported back pain due to the incident.Following the event the thigh plates were mounted on the 113070ac maquetmatic.There was no injury of the patient reported.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.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Manufacturer Narrative

Getinge became aware of an incident with one of our table tops ¿ 116010a0 - universal table top, ipc, eu used with 113070ac maquetmatic during surgery.As it was stated, the patient was operated in gynecological position with legs in knee crutches.At the end of surgical procedure, the legs were lowered by the medical staff, what resulted in the anesthetized patient sliding down on the table top between central part and knee crutches.The staff supported the patient and pulled her up on the table top.The procedure was delayed by approximately 15 minutes.The staff member reported back pain due to the incident.Following the event the thigh plates were mounted on the 113070ac maquetmatic.There was no injury of the patient reported.We decided to report the issue based on the potential for serious injury if the situation, namely patient sliding down the table top, causing the delay in surgery resulting in prolonged anesthesia time, was to reoccur.The affected getinge device has been evaluated by the company¿s service technician.The technician could not find any technical malfunction with the claimed devices.They confirmed that the devices¿ pads were covered with drapes.They mentioned that only the patient¿s legs were secured with belts.According to them the space between the universal table top and the maquetmatic knee crutches was too far.The devices were released to usage.The subject matter expert at manufacturing site stated that based on complaint information he did not see any malfunction of the devices.According to the sme the patient was not secured properly.The sme has upheld the scenario assessment performed by the clinical expert, who established that the workflow of the patient positioning was not sufficient.He assessed that without pushing the patient back upward, while lowering the legs of the patient mounted in maquetmatic 113070ac, the patient would slip in the space between the accessory and the table top.This scenario was reflected in the reported issue.In the ifu (ifu 1160.10 en 06, page 21), the user is warned that if the patient is not secured, particularly when adjusting/moving, the patient and/or their extremities may slip in an uncontrolled manner.The user shall always secure the patient using suitable aids (e.G.Straps) and maintain continuous observation.In the ifu (ifu 1160.10 en 06, page 20), there is also a safety note regarding the risk related to the improper positioning, which may cause health damage.The user shall ensure to position the patient correct and keep under constant observation.It is likely that the user utilized the accessory disregarding safety notes and suggestions from the user manual.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, thus was also directly involved with the reported incident.As no malfunction of the table top and maquetmatic was found, it was considered that the getinge devices were up to their specification.Based on all available information we assume that the root cause for patient sliding down the table top, causing the delay in surgery resulting in prolonged anesthesia time was most likely related to the user error.The complaint investigated herein is a single and isolated case.We currently do not have any information that would warrant further action towards the 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 h4 device manufacture date field deems required.This is based on the internal evaluation.Previous h4 device manufacture date: 10/01/2022.Corrected h4 device manufacture date: 06/21/2022.

Event Description

Manufacturer's reference number (b)(4).

• Brand Name: UNIVERSAL TABLE TOP, IPC, EU
• Type of Device: 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: 16664022
• MDR Text Key: 312608172
• Report Number: 8010652-2023-00030
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 116010A0
• Device Catalogue Number: 116010A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2022
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 113070AC MAQUETMATIC.
• Patient Sex: Female
• Patient Weight: 125 KG