MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL C500; POWERED WHEELCHAIR

Model Number C500

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problems Bone Fracture(s) (1870); Laceration(s) (1946); Injury (2348); Tooth Fracture (2428)

Event Date 02/14/2020

Event Type  Injury  

Manufacturer Narrative

Report indicated as the end-user was in process of dressing themselves, they were resting their weight on the armrest of the seating for support.During this process, it was reported the armrest suddenly gave way and fell down from the horizontal position.This loss of armrest positioning reportedly caused the end-user to lose their balance and fall to the floor.Reports indicate the end-user was taken to the hospital where they were diagnosed as having suffered fractured teeth and various lacerations to their nose and chin, some requiring stitches to remedy.Inspection of the device shown the threaded rod portion of the link arm (which maintains the armrest angle) on the right side armrest having broken where it attaches to the armrest.This failure allowed the armrest to lose support and fall down.The corpus 3g user manual, which was provided with the device, indicates safety warnings outlining the armrest as not being intended to sustain heavy loads.At this point permobil is unable to determine the root cause of the component failure.Investigation will continue and upon receipt of any new information a follow-up report will be submitted.The dhr was reviewed and the device met specification prior to distribution.

Event Description

Received report claiming as the end-user was leaning on the armrest while attempting to dress, the right armrest was reported to have fallen down causing the end-user to lose balance and fall to the floor.The fall was reported to have resulted in an injury requiring medical intervention.

Manufacturer Narrative

Inspection of the device shown the threaded rod portion of the link arm (which maintains the armrest angle) on the right side armrest having broken where it attaches to the armrest.This failure allowed the armrest to lose support and fall down.The broken armrest screw was sent to permobil ab for investigation.The end-users weight is reported to be approximately 70kg (154lbs) and the wheelchair is equipped with 335mm (13in) long armrests.Initial inspection did not indicate any signs of physical damages having been sustained to have potentially contributed to the break.The affected component was sent to an external, third party, company (kiwa inspecta) to perform material analysis and tensile pull-test.The documented results received from kiwa inspecta concluded the material was within specification.Further evaluation was performed by permobil technical engineering who determined the failure was the result material fatigue.Calculations for fatigue failure in the material indicate the user weight combined with armrest length should not caused this failure to occur under normal use.Permobil is unable to determine the root cause of this failure, but will continue to monitor through trend analysis.The corpus 3g lr user manual, which was provided with the device, indicates safety warnings outlining the armrest as not being intended to sustain heavy loads.The end-user has been verbally instructed to refrain from using the armrests as a weight bearing surface and informed to reference the user manual which was provided to them.The dhr was reviewed and the device was found to have met specification prior to distribution.

• Brand Name: PERMOBIL C500
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 861 3 6; SW 861 36
• MDR Report Key: 9854642
• MDR Text Key: 184113938
• Report Number: 1221084-2020-00015
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K991658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C500
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 70