MAUDE Adverse Event Report: MAQUET GMBH ARM BOARD; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 10016000

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907); Device Fell (4014)

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

Event Date 12/01/2022

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.E1 event site name: huaxi no.2 hospital of sichuan university h3 other text : device not returned to manufacturer.

Event Description

On 1st june 2023 getinge became aware of an incident with one of our accessories - the hand rest used with 113112b0 - betastar mobile operating-table, eu during the hysterectomy surgery.As it was stated, the hand rest detached and fell down leading to an impact on the surgeon's foot and a sudden change in the position of patient's left arm.According to the provided information, at the beginning of the procedure, nurse firmly fixed the hand rest to the table and positioned patient's arm, and the accessory was not moved during the surgery.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of the accessory used for patient's positioning could lead to serious injury of patient or user in case of event reoccurrence.

Event Description

On 1st june 2023 getinge became aware of an incident with one of our accessories - 10016000 arm board used with 113112b0 - betastar mobile operating-table, eu during the hysterectomy surgery.As it was stated, the arm board detached and fell down close to the surgeon's foot but it did not hit the user's foot.The incident led to a sudden change in the position of patient's left arm.There was no surgery delay.According to the provided information, at the beginning of the procedure, nurse firmly fixed the arm board to the table and positioned patient's arm, and the accessory was not moved during the surgery.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of the accessory used for patient's positioning could lead to serious injury of patient due to change in the position of patient¿s hand or user due to impact to foot or toes in case of event reoccurrence.

Manufacturer Narrative

Getinge became aware of an incident with one of our accessories - 10016000 arm board used with 113112b0 - betastar mobile operating-table, eu during the hysterectomy surgery.As it was stated, the arm board detached and fell down close to the surgeon's foot but it did not hit the user's foot.The incident led to a sudden change in the position of patient's left arm.There was no surgery delay.According to the provided information, at the beginning of the procedure, nurse firmly fixed the arm board to the table and positioned patient's arm, and the accessory was not moved during the surgery.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of the accessory used for patient's positioning could lead to serious injury of patient due to change in the position of patient¿s hand or user due to impact to foot or toes in case of event reoccurrence.The affected getinge devices have been evaluated by the company¿s service technician.The technician could not find any issue with the arm board and operating table.The devices were released to usage.Video evidence showing the issue with arm board locking faced by the customer was provided by the ssu.The customer alleged that the arm board is not easy to fasten during the installation process and the clamp is hard to lock to the operating table side rail firmly.The customer also pointed out that the clamp is easy to get loose and may fall off.According to the feedback from the operating nurse, the clinical operation is always very urgent and the arm board may need to be adjusted during the operation.As she states in the video and operation demo, since the rail clamp cannot be firmly locked, there might be a safety risk for both patient and operator.In the ifu (ifu 1001.60 en 12, pages 16-17), it is described that when attaching the arm board to the side rail, the first clamp should be mounted, tightened and checked for proper seating.Then the arm support can be mounted.In the video, the nurse tried to adjust the arm board in a different way than it is described in the ifu.The subject matter expert at the manufacturing site was contacted to assess the root cause of the issue.The sme stated that adjusting the arm board on the side rail, as done by the nurse, is not forbidden as long as the safety notes are followed, however, it might cause some difficulties with attaching it firmly.In the ifu (ifu 1001.60 en 12, page 12), the user is warned that if locking elements (eccentric levers, handle screw, locks etc.) are open, the product/accessory can be moved.Therefore, before every opening of the locking elements, the user should hold the individual items firmly and after every adjustment procedure should ensure that all locking elements are closed.In the ifu (ifu 1001.60 en 12, page 12), the user is also warned that when adjusting and moving the or table, the transporter or the accessories, as well as when carrying out a table top transfer, collisions may occur between the patient and individual products or parts that are pointing downwards.During adjustments, the user should observe the devices constantly and avoid collisions.The user shall also ensure that tubes, cables and drapes are not trapped.Additionally, based on the video, the nurse was screwing the clamp incorrectly as she tried to screw it horizontally, not vertically as shown in ifu (ifu 1001.60 en 12, page 16), which led to an issue with firm locking.The sme has recommended using the product as described in the ifu: first close the screw from the clamp, so there is enough space to rotate the screw and then mount/ fix the arm support.It is evident that the user utilized the accessory disregarding safety notes and suggestions from the user manual.To conclude, the sme assessed that the issue was caused by improper handling.The subject matter expert provided a video for the customer to present the correct handling of the device.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 arm board was found, it was considered that the getinge device was up to the specification.In summary and as a result of performed by the subject matter expert root cause evaluation, it can be concluded that the root cause of the reported issue is caused by user error related to the improper handling and mounting of the arm board.There was one similar customer product complaint related to this issue investigated here where the arm board detached from the operating table but did not lead to serious injury, therefore the failure ratio for the issue investigated herein is 0,0028% for the 10016000 - arm board.The failure ratio for the configuration of the 10016000 - arm board and 113112b0 - betastar mobile operating-table is 0,0026%.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.

Event Description

On (b)(6) 2023 getinge became aware of an incident with one of our accessories - 10016000 arm board used with (b)(6)- betastar mobile operating-table, eu during the hysterectomy surgery.As it was stated, the arm board detached and fell down close to the surgeon's foot.It has been confirmed that the arm board did not hit the user's foot.The issue led to a sudden change in the position of patient's left arm.According to the provided information, at the beginning of the procedure, nurse firmly fixed the hand rest to the table and positioned patient's arm, and the accessory was not moved during the surgery.There was no injury reported, however, we decided to report the issue in abundance of caution as detachment of the accessory used for patient's positioning could lead to serious injury of patient or user in case of event reoccurrence.

Manufacturer Narrative

According to the reporting timeframe we would like to provide the information about current status of the issue.Please be advised that it is being investigated.Additional information will be provided following the conclusion of the investigation.The correction of d1 brand name, d2 common device name, d4 version or model #, d4 catalog #, d4 serial # and h4 device manufacture date fields deems required.This is based on the additional information that has been received.Previous d1 brand name: betastar mobile operating-table, eu corrected d1 brand name: arm board previous d2 common device name: fqo table, operating-room, ac-powered corrected d2 common device name: bwn, table and attachments, operating-room previous d4 version or model #: 113112b0 corrected d4 version or model #: 10016000 previous d4 catalog #: 113112b0 corrected d4 catalog #: 10016000 previous d4 serial #: (b)(6)corrected d4 serial #: n/a previous h4 device manufacture date: 09/01/2017 corrected h4 device manufacture date: n/a.

• Brand Name: ARM BOARD
• 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: 17075214
• MDR Text Key: 316800786
• Report Number: 8010652-2023-00044
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2023

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: 10016000
• Device Catalogue Number: 10016000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2023
• Initial Date FDA Received: 06/06/2023
• Supplement Dates Manufacturer Received: 06/16/2023; 07/20/2023
• Supplement Dates FDA Received: 07/12/2023; 07/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 113112B0 - BETASTAR MOBILE OPERATING-TABLE