MAUDE Adverse Event Report: MAQUET GMBH EXTENSION DEVICE; TABLE AND ATTACHMENTS, OPERATING-ROOM

Model Number 118019A0

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Head Injury (1879)

Event Date 01/26/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2023 getinge became aware of an incident with one of our accessories ¿ 118019a0 - extension device.As it was stated, during preparation for procedure, surgical team was positioning the patient on traction device.The patient's right foot was already fixed on traction device and left foot was lifted up on leg holder.L-shaped side support was on the right side of the patient.The surgical team added traction to the patient's foot and the patient fell on the floor.According to provided information, there is no indication that any kind of body straps or additional supports on the patient's upper body were used.The patient had minor wounds on head.No additional injuries were found during examination.At the time of incident, the patient was fully conscious.The original procedure was completed after the examination.We decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table was to reoccur.

Manufacturer Narrative

Getinge became aware of an issue with one of our accessories ¿ 118019a0 - extension device.As it was stated, during preparation for the procedure, the surgical team was positioning the patient on a traction device.The patient's right foot was already fixed on the traction device and the left foot was lifted up on the leg holder.L-shaped side support was on the right side of the patient.The surgical team added traction to the patient's foot and the patient fell on the floor.At the time of the incident, the patient was fully conscious.According to available information, no kind of body straps or additional supports were used on the patient's upper body at that time.As an effect of the fall, the patient sustained minor wounds on the head.The original procedure was completed after the examination.We decided to report the issue based on the potential for serious injury if the situation, namely the patient falling off the table was to reoccur.The affected getinge device was evaluated by the service technician.All functions of the extension device were tested.The technician did not find any malfunctions and concluded device to work according to specification.The root cause evaluation performed by the medical expert from the manufacturing site revealed that the side support was not in the correct position at the thorax and it did not secure the patient from falling down.According to information provided by medical expert, if traction is applied to the patient¿s leg and the non-operative leg is placed in the leg holder, the pelvis of the patient starts to move/rotate on the counter traction post and the whole upper body moves to the right side where traction is applied (like in the reported incident).The harder the leg is pulled, the more movement is generated in this direction.If the side support, which should stop this outward movement of the patient¿s body, is positioned in the wrong place, the body of the patient could slip away from the body support.In consequence, no support is given and the upper body slips from the table.In the user manual (ifu 1180.19 en 13 page 14 and 18), the user is warned that there is a risk to the patient's vital functions due to incorrect positioning and that improper patient positioning may cause health damage.The user is also informed to position the patient correctly and keep under constant observation.In addition, the user did not use the body straps to secure the patient during positioning.In the user manual, 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 and to always secure the patient using suitable aids (e.G.Straps) and maintain continuous observation.The root cause for the patient fall of the extension device was user error related to inappropriate patient positioning and non-compliance with the instruction for use.The additional positioning training was to be performed for user in order to prevent similar situation in the future.With the investigation performed it was concluded that upon the event occurrence, the device was being used for the patient¿s treatment, and thus was also directly involved with the reported incident.As no malfunction with the device was found, it was considered that the getinge device was up to specification.There were no similar complaints found related to this issue failure pattern as described in this event, therefore it appears to be isolated to this single occurrence when considering this particular device range.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 b1 adverse event / product problem field deems required.This is based on the internal evaluation.Previous b1 adverse event / product problem: product problem.Corrected b1 adverse event / product problem: adverse event & product problem.

Event Description

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

• Brand Name: EXTENSION DEVICE
• 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: 16271538
• MDR Text Key: 308757283
• Report Number: 8010652-2023-00008
• Device Sequence Number: 1
• Product Code: BWN
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118019A0
• Device Catalogue Number: 118019A0
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other