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

Model Number F3

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

Patient Problems Sprain (2083); Swelling (2091)

Event Date 11/21/2019

Event Type  malfunction  

Manufacturer Narrative

Report given claimed as end-user was traversing at full speed down a street in their neighborhood, the device reportedly stopped without warning.When this occurred, it was reported to have caused the end-user to lean forward due to momentum.With the end-user leaning forward and reportedly driving down a slight incline in the road, the device tipped forward which caused the footplates to dig into the asphalt stopping the device.It was reported the end-user was secured in the seating with a positioning belt and the forward momentum of their body weight caused the device to fall over forward to where the end-user landed on their knees.Reports indicate the end-user was taken to the local er for evaluation to where they were released with sprained ankles, no serious injuries were sustained.Inspection of the device indicated a error having occurred in the main power module to where it was receiving an error indicating a motor brake issue.When the system receives this error, i.E.Device placed into freewheel, it will place the device into a drive inhibit until the issue causing the error is corrected.If this type of error were to occur while the device is being driven, the system will bring the device to a controlled stop.Device shown signs of having been exposed to moisture over an extended period of time due to high levels of rust and corrosion throughout the device.Inspection of the power module shown signs of being exposed to moisture and as such is determined to be the root cause of the failure.A new power module was installed on the device and all drive functions were restored and device returned to the end-user with no further issues being reported.The dhr was reviewed and device met specification prior to distribution.

Event Description

Report received claiming while end-user was driving at speed down an inclined road, the device suddenly stopped without notice.This allegedly caused the chair to tip forward, driving the footplates into the ground.With the end-user being belted in, the momentum reportedly tipped the device over forward to where the end-user struck both their knees on the pavement.No serious injuries were reported to have been sustained.

• 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: 9505901
• MDR Text Key: 184122316
• Report Number: 1221084-2019-00061
• Device Sequence Number: 1
• Product Code: ITI
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• 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: 12/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 64