MAUDE Adverse Event Report: PERMOBIL INC. 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	10/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports provided by the spouse indicate the end-user was sitting in the device's seating while under supervision of a caregiver and family member.At some point the end-user was left alone in the living room and when the caregiver came back into the room, they saw the end-user laying on the floor.Reports claim the end-user was taken to the hospital for evaluation where they were diagnosed as having sustained an fx to their right hip.The spouse relayed they were not witness to the event but had noted the end-user has been having issues where they cannot maintain position in the seating and having tendency to slide forward.The spouse reported to permobil representative that the device did not malfunction, and it is their belief that the end-user had an episode which caused themselves to slide forward and out of the seating.The end-user was not wearing their positioning belt at the time of the event.Permobil representative reports the end-user has physical limitations to their right leg which does not allow them to place their foot fully upon the footplate, leaving only their left foot for support.It was also noted the end-user's condition has left them with little muscle control requiring the need to use the device in a partial tilt to position farther back in the seating.The permobil representative had inspected the device finding it to fully operational with no signs of mechanical or electrical issues having occurred.Further training was conducted with the end-user and family of the need to wear the incorporated positioning belt whenever occupying the devices seating.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming while the end-user was occupying their power wheelchair inside their home, they reportedly lost positioning and slid out of the seating to the floor.Reports indicate the fall resulted in 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: 12770577
• Report Number: 1221084-2021-00037
• Device Sequence Number: 3144578
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2021

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: 10/21/2021
• Initial Report FDA Received Date: 11/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male