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

Model Number F5 CORPUS VS

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problems Myalgia (2238); Muscle/Tendon Damage (4532)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Preliminary reports indicate this specific wheelchair is equipped with 2 different steering devices and both are attached to the backrest of the wheelchair to be used as attendant controls by a caregiver.When the incident occurred, it was reported the caregiver attempted to move the wheelchair forward by one of the steering devices (the co-pilot), the wheelchair moved in the opposite reverse direction.This reportedly caught the caregiver off guard which caused them to strain their wrist.The service provider requested permobil to inspect the device and in effort to determine a potential root cause, the suspect co-pilot control is being returned to permobil ab manufacturing headquarters for a full evaluation.At the time of this report, the evaluation has not been performed therefore a determination cannot be made.Upon the completion of the evaluation, a follow-up report will be submitted to include permobil's findings.

Event Description

Permobil ab received report claiming while the caregiver was attempting to move the device in a forward direction via the co-pilot attendant control, the device allegedly operated in the opposite direction than was expected.This unexpected action reportedly caused the caregiver to strain their wrist.No medical intervention was sought as a result.

Manufacturer Narrative

The co-pilot attendant control was replaced with a new unit while suspect control was sent to permobil ab for analysis.The wheelchair has been returned to the end-user with no further issues being reported.The suspected affected component, co-pilot attendant control, was returned to permobil ab for inspection and functional testing.No visual damages were noted, and all sensors were found to be properly positioned and fully functional during operational testing.Response from the unit during test drive was as per intended design with installed safety measures (dead mans grip) working as intended.Permobil ab was unable to conclude a malfunction had occurred with the co-pilot control.Permobil has determined the probable cause of the report of unintended movement was use error in not following operational instructions that were provided in the user manual and warning labeling on the device component.

• 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: 11603515
• MDR Text Key: 246765066
• Report Number: 1221084-2021-00010
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1