MAUDE Adverse Event Report: PERMOBIL AB (PAB) F5 CORPUS VS; POWERED WHEELCHAIR

Model Number F5 CORPUS VS

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2021

Event Type  Death  

Manufacturer Narrative

This incident was reported to have occurred at the facility where the end-user was residing.The end-user was reported to have been utilizing the f5 corpus vs for approximately one year prior to the event and is presumed to be familiar with the operational functions of the device.According to the information provided, the user initiated the stand-up function on the wheelchair, but without wearing the needed positioning aids used for safety and that will keep them positioned in the seating during the stand-up procedure.According to the care protocols in the facility, users should always be belted, but in this case, it was reported the end-user was not utilizing the trunk harness that the wheelchair is equipped with.Personnel at the facility reported not knowing if the end-user did not realize they were not wearing the positioning aids, or if it was a deliberate action.During the standing procedure it was reported the user's upper body had fallen forward.When that was noticed by facility personnel, the end-user was immediately positioned back into the seat unit by the caregivers.Reports indicate the end-user claimed feeling dizzy after the incident and was reported to have lost consciousness sometime later.A call was made for emergency services, but after an undisclosed amount of time, reports claim the end-user subsequently deceased.With the limited information provided by the facility staff, permobil is unable to reach a determination if the subsequent death was related to the incident, or due to a pre-existing issue.All information received thus far indicates the incident was caused by a human error in combination with unfortunate circumstances.No claims nor allegations were made of the product having malfunctioned or deviated in a manner to which this incident would be attributed.Further communication with concerned parties having knowledge of the incident will continue in effort to gather a better understanding as to the cause of death.If upon the receipt of any new information, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Permobil ab received a report claiming the end-user having initiated the stand-up function on their wheelchair without utilizing any upper body supports.Report claims the end-user fell forward and upon being noticed, aides assisted end-user back into seating.Report claims shortly after the event, the end-user lost consciousness and subsequently deceased.

Manufacturer Narrative

Further communication with facility personnel claim they follow a care protocol stating that all their clients in wheelchairs should wear positioning aids when they are in use.Reports indicate on this specific day, the user themselves choose not to wear the upper body support (the torso harness) when they were going to drive outside the facility to a patio.The personnel cannot provide an explanation why the user started the stand-up function on their wheelchair without wearing the torso support as they always wore them in the past during these circumstances.Staff members assume the end-user did not realize or had forgotten they were not wearing them.According to information provided, the end-user maintained full cognitive ability, and the facility maintains the incident was caused by user error in not following the protocol with attaching the needed supporting aids for this kind of advanced device.The wheelchair was found to be working as intended and all persons involved with this incident are aware of the importance to always wear support aids during the use of the stand-function, as outlined in the user manual.Permobil has attempted to obtain clarifying information as to the actual cause of death but are unable to obtain this information due to gdpr regulations and the facility staff's duty to maintain confidentiality.

• Brand Name: F5 CORPUS VS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86102 3; SW 861023
• MDR Report Key: 11652193
• MDR Text Key: 244995537
• Report Number: 1221084-2021-00013
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K191874
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5 CORPUS VS
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death