MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number	M3
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report provided to permobil claims as the end-user was driving down a ramp, the wheelchair was reported to have suddenly stopped which caused the end-user to fall out of the devices seating to the ground.Reports indicate the end-user was taken to the local hospital for evaluation where they were diagnosed as sustaining minor injuries consisting of general bumps and bruises.The end-user reported having 2 separate incidents earlier in the day where the device had stopped, but they were able to retain their positioning.The local service provider evaluated the device and contacted permobil technical support to diagnose the potential issue.It was determined an issue with the joystick controller was the possible cause and the joystick was replaced with new.Reports indicate after replacement of joystick; the device was fully operational with no recurring issues.Permobil has not yet received the suspect component for inspection/evaluation therefore a determination as to root cause cannot be reached.If any new information is received, a follow-up report will be submitted.The dhr was reviewed and device was found to have met specification prior to distribution.
Event or Problem Description
Permobil received report claiming while end-user was operating their wheelchair down a ramp, the wheelchair reportedly stopped which caused the end-user to lose positioning and fall out of the device seating to the ground.Report indicates the end-user was taken to local hospital for evaluation where they were diagnosed as having sustained minor injuries.
Additional Manufacturer Narrative
Permobil received suspect component (joystick control) for inspection.Visual shown the joystick to be in good physical condition with no apparent external damages.Examination of internal components did not indicate any loose connections with all connectors being securely seated.Test operation of the joystick was unable to re-create the reported failure of 080a (joystick out of center), with joystick operating normally under test conditions.Suspect component was sent to supplier, curtiss wright, for a more thorough evaluation.Supplier reports their testing was unable to replicate any failures with component, and no indications of a failure having occurred that would allow them to determine a probable root cause.As no component malfunction could be identified, and reports of the device being fully operational with no reports of recurring behavior; permobil remains unable to confirm a product malfunction occurred.Permobil will continue to monitor for any reports of recurring behavior through trend analysis.

• Brand Name: PERMOBIL M3
• Common Device Name: 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: 13336928
• Report Number: 1221084-2022-00002
• Device Sequence Number: 17123183
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K123290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose