MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F3; POWERED WHEELCHAIR

Model Number F3

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hematoma (1884); Skin Discoloration (2074)

Event Date 08/08/2020

Event Type  malfunction  

Manufacturer Narrative

Reports received claim as the end-user was out of doors in their driveway, attempted to perform a turn to go up the drive.Claims indicate the left rear caster fork detached which caused the device to drop down and to the left.This action reportedly forced the end-users weight to shift to the left causing the device to tip over on to its left side.Reports claim when this occurred, the end-user landed with their left hip contacting the left armrest.End-user was admitted into hospital due to pain in their hip where they were diagnosed as not having suffered any fractures, but had sustained heavy bruising to their left hip and thigh.Service provider confirmed the fork detachment, finding the hardware that secures the left fork missing.The dealer relayed the client uses the device in a more rural setting of unpaved / unlevel surfaces which is the primary make up their property, rendering it difficult to determine where the hardware detached.Device history indicates previous service having been performed to where this hardware kit was ordered and replaced 1 year prior of this reported incident.Dealer stated they could not confirm when the hardware loosened and detached as they had not received any reports or requests for service since that last repair.With the information provided and the inability to locate the missing hardware for inspection, permobil is unable to reach a determination as to root cause without speculation.Dealer has been provided replacement components to repair the device with guidance to refer to the service manual for proper installation.The dhr was reviewed and device was found to have met specification prior to distribution.

Event Description

Received report while end-user was out of doors, when attempting to turn the device around to return to their home, the left rear caster fork was reported to have detached from the device which reportedly caused the device to fall over to the left side with end-user.Reports indicate the end-user sustained an injury requiring brief hospitalization.

• Brand Name: PERMOBIL F3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 10993217
• MDR Text Key: 220979733
• Report Number: 1221084-2020-00054
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818676433
• UDI-Public: 17330818676433
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 79