MAUDE Adverse Event Report: MAQUET GMBH FIXTURE FOR BODY SUPPORTS; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 100219C0

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On 25th october, 2022 getinge became aware of an issue with one of accessories ¿ 100219c0 - fixture for body supports.As it was stated, the patient partially fell off the operating table during positioning.The patient did not hit ground or any object.The staff adjusted patient's position and the operation continued without complications.There was no injury reported, however, we decided to report the issue in abundance of caution based on the potential the similar event could lead to serious injury in case of event recurrence.

Manufacturer Narrative

Getinge became aware of an issue with one of the accessories ¿ 100219c0 - fixture for body supports used with 113112b0 betastar operating table.The patient partially fell off the operating table during positioning.The patient did not hit the ground or any object.The staff adjusted patient's position and the operation continued without complications.There was no injury reported, however, we decided to report the issue in abundance of caution based on the potential for serious injury if the situation, namely patient partially falling off the table, was to reoccur.The affected getinge device has been evaluated by the company¿s service technician.The technician observed that the joints must have been under-tightened, as all clamping joints were working properly.According to all available information, no malfunction with the fixture for body supports could be found.In the instruction for use (ga 1002.19 en 11, page 5) there is information that the fixture 100219c0 is designed to be used to mount certain body supports to secure the patient.Any use other than that is not in compliance with the intended purpose.In the ifu (ga 1002.19 en 11, page 6) the user is warned about the risk coming from improper handling, incorrect positioning and unauthorized modifications of the device.The user is also warned that if a product or accessory is not fixed properly it may become loose and lead to injury (ga 1002.19 en 11, page 7).As it is very likely that the user utilized the accessory disregarding safety notes and suggestions from the user manual, the root cause for this issue is user error.The sales representative has trained the staff how to use the device properly.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 with the fixture for body supports could be found, it was considered that the getinge device was up to the specification.In summary, this complaint is the first one registered on maquet gmbh fixture for body supports with catalog number 100219c0 where the patient partially fell off the table.Comparing the number of complained devices (1) to the number of units placed on the market (60258) we can conclude the failure ratio is 0,002% for the issue investigated herein and that this 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 d1 brand name, b5 describe event or problem, h8 usage of device fields deems required.This is based on the internal evaluation.Previous d1 brand name: accessories universal corrected d1 brand name: fixture for body supports previous b5 describe event or problem: on 25th october, 2022 getinge became aware of an issue with one of accessories ¿ 100219c0 - fixture for body supports.As it was stated, the patient partially fell off the operating table during positioning.The patient did not hit ground or any object.The staff adjusted patient's position and the operation continued without complications.There was no injury reported, however, we decided to report the issue in abundance of caution based on the potential the similar event could lead to serious injury in case of event recurrence.Corrected b5 describe event or problem: on 25th october 2022 getinge became aware of an issue with one of the accessories ¿ 100219c0 - fixture for body supports used with 113112b0 betastar operating table.The patient partially fell off the operating table during positioning.The patient did not hit the ground or any object.The staff adjusted patient's position and the operation continued without complications.There was no injury reported, however, we decided to report the issue in abundance of caution based on the potential for serious injury if the situation, namely patient partially falling off the table, was to reoccur.Previous h8 usage of device: unknown corrected h8 usage of device: reuse.

Event Description

On 25th october 2022 getinge became aware of an issue with one of the accessories ¿ 100219c0 - fixture for body supports used with 113112b0 betastar operating table.The patient partially fell off the operating table during positioning.The patient did not hit the ground or any object.The staff adjusted patient's position and the operation continued without complications.There was no injury reported, however, we decided to report the issue in abundance of caution based on the potential for serious injury if the situation, namely patient partially falling off the table, was to reoccur.

• Brand Name: FIXTURE FOR BODY SUPPORTS
• Type of Device: TABLE AND ATTACHMENTS, OPERATING-ROOM
• 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: 15689759
• MDR Text Key: 303652748
• Report Number: 8010652-2022-00037
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: EZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

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 Operator: Health Professional
• Device Model Number: 100219C0
• Device Catalogue Number: 100219C0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 10/28/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1