MAUDE Adverse Event Report: PERMOBIL M3; POWERED WHEELCHAIR

Model Number	M3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hip Fracture (2349)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The client claimed that while she was driving the chair out of a dollar general store, she didn't recall exactly what happened, but thinks she may have blacked out and remembers being on the ground with the chair on top of her (still upright).Client reported that a bystander who helped get the chair off her claimed the chair was off but was somehow still moving.Reports indicate the end-user was taken to a local hospital where it was reported they sustained a fractured hip requiring surgery to address.Dealer stated the end-user did not report the event until just recently and could not specify exactly when the event occurred, but recalls the event occurring sometime in (b)(6) 2020.The service provider reports having inspected the device and did not notice any damages that would indicate the device having impacted anything.Dealer performed a full operational testing of the device and was unable to detect any abnormalities, finding the device to be fully functional.As no product malfunction could be identified, and the end-user has no recollection if the device deviated in any way to have contributed to their falling, permobil in unable to reach a determination as to root cause without speculation.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
End-user reports as they were driving out of a store front, they do not recall exactly what happened, but next thing they knew they were on the ground and the wheelchair was on top of them.Reports indicate they sustained severe injuries requiring medical intervention as a result of the fall.

• Brand Name: PERMOBIL M3
• Common Device Name: POWERED WHEELCHAIR
• MDR Report Key: 12464731
• Report Number: 1221084-2021-00032
• Device Sequence Number: 14434290
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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: 08/16/2021
• Initial Report FDA Received Date: 09/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2020
• 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 Weight: 97