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

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Device Tipped Over (2589); Detachment of Device or Device Component (2907); Unintended Movement (3026)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user reported to permobil representative that while they were driving along the street, the "left" rear caster fork assembly reportedly detached from the suspension arm.The end-user recounted that this caused the device to become unstable and fall over on to its "right" side.End-user reported having gone to the va medical center where they were diagnosed as having sustained a cracked rib and injury to finger on their right hand with loss of fingernail.Device was inspected by permobil representative who noted both rear caster fork assemblies were installed with device being fully operational and no indications of a malfunction having occurred as described.End-user claims a local law enforcement official saw the event, assisted the end-user back into the device, and subsequently reinstalled the fork.As the device was fully operational and mechanically sound at time of inspection; permobil is unable to confirm a product malfunction having occurred, thus is unable to establish a probable root cause without speculation.The dhr was reviewed and device was found to have meet specification prior to distribution.
Event or Problem Description
Received report from end-user stating while driving their power wheelchair along a street, reports the left rear caster fork detached.This reportedly caused the powered wheelchair to fall over on to its right side, resulting in an injury that required medical intervention.

• 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: 16627180
• Report Number: 1221084-2023-00005
• Device Sequence Number: 12089928
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Prefer Not To Disclose