Model Number F3 CORPUS |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907)
|
Patient Problems
Bone Fracture(s) (1870); Limb Fracture (4518)
|
Event Date 11/11/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
Initial reports received allege the left footplate having detached from the legrest assembly causing the end-user's foot to fall underneath the drive wheel of the wheelchair.This event is reported to have cause the user injury.Interview with the end-user's wife indicate that some swelling and bruising was identified around the left ankle 2-days after the event.Permobil has requested to inspect the wheelchair and is making arrangements to verify the circumstances surround the reported failure.Therefore, investigation into root cause is pending at this time.After an evaluation of the device is complete and a determination into root cause of the failure is further understood, a follow-up report will be submitted.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
|
|
Event Description
|
Received report from end-users wife claiming the left footplate slid out of the receiver bracket.This allowed the end-users foot to drop down which reportedly got caught under the drive wheel causing a fracture to the left tibia.
|
|
Manufacturer Narrative
|
Permobil representative inspected the device and found the footplate reported to have detached had been re-installed by the end-user.The description of the event indicated the hardware designed to secure the leg tube and footplate to the leg rest assembly had loosened which allowed the footplate assembly to fall out of the receiver.Inspection shown all hardware remained intact and no physical or mechanical defects were noted.Through interviews with the end-user, it was reported the end-user routinely applies pressure to the footplates to re-position themselves.The end-user reported not having any routine service performed to the leg rest/footplate assembly since initial receipt 1.5 years prior.Permobil representative concluded that without general maintenance, overtime, the hardware that secures the leg tube to the leg rest assembly became loose allowing the footplate to detach.The end-user was verbally instructed that routine maintenance should be performed as outlined in the user manual.
|
|
Search Alerts/Recalls
|