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

Model Number	M3
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil legal counsel received a copy of letter of petition, filed by the end-user against their service provider, where it was alleged that the end-user was thrown from their device after an un-descriptive malfunction occurred.This event reportedly resulted with the end-user sustaining un-descriptive injuries to their hip, back and neck.This event was reported to have occurred approximately 2 years prior to permobil being made aware.Review of device history does not indicate any service-related inquiries having been placed in/around the timeframe the event was reported to have occurred ((b)(6) 2019).Due to the 2-year timeframe from when the event was reported to have occurred, and the limited information provided in the petition; permobil is unable to confirm a device malfunction occurred and therefore a determination as to probable root cause cannot be established at this time.If any new information is received, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Permobil received report claiming while end-user was operating their device, an undescriptive malfunction occurred which reportedly caused the end-user to be thrown forward, out of the seating, where they sustained injuries requiring medical intervention to address.

• 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: 12916763
• Report Number: 1221084-2021-00040
• Device Sequence Number: 5222858
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2018
• 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: Other
• Patient Sex: Prefer Not To Disclose