MAUDE Adverse Event Report: PERMOBIL M3; POWERED WHEELCHAIR

Model Number M3

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problems Bone Fracture(s) (1870); Limb Fracture (4518)

Event Date 06/18/2021

Event Type  Injury  

Manufacturer Narrative

Permobil received email correspondence from the end-user where they described a failure having occurred where the footplate assembly of the seating having detached which caused the end-user to lose positioning and fall out of the seating to the ground.The end-user reported having sustained fractures to their shoulder and arm requiring medical intervention to address.Photo provided by the end-user of the device in its current state depicts the legrest assembly that appears to indicate the outer leg tube which the footplates are secured had become detached from the inner tube.A root cause of the reported failure cannot be determined at this time, without speculation, as the device has not been made available for inspection.Permobil will continue its investigation, and upon 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

Received report from end-user claiming having received a severe injury due to an alleged malfunction with the footplate/legrest which caused them to fall out of seating to the ground.

Manufacturer Narrative

Device was inspected by a permobil representative who determined the cause of the footplate detachment was the loosening of fasteners of a bracket that secures a web belt which controls footplate articulation during elevation.Inspection shown the web belt and bracket to remain fully intact, but the hardware that secures the bracket to have loosened, over time, which allowed the web belt to slip when weight was applied to the footplates.The end-user reported not having had any service or routine maintenance performed involving the leg rest assembly since acquiring the device.The permobil representative was able to re-install the footplate assembly and adjust to meet the client's physical needs.The end-user was given recommendation that routine service be performed by their service provider to ensure their device remains in proper, safe operation.Permobil was unable to determine a component failure having occurred, concluding the probable cause of the reported event being related to lack of routine maintenance.

• Brand Name: PERMOBIL M3
• Type of Device: POWERED WHEELCHAIR
• MDR Report Key: 12277523
• MDR Text Key: 265205823
• Report Number: 1221084-2021-00025
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (y/n): N
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization