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); Limb Fracture (4518)
Date of Event	11/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reports provided indicate when the end-user was in the shower, they reportedly lost their balance and fell forward out of the seating to the floor of the shower.This fall reportedly resulted with the end-user having sustained a fracture to their left tibia.Reportedly the end-user utilizes the device in this manner on a routine basis while keeping the device covered to protect from moisture.Service provider stated having inspected the device and found it to be operating normally with no signs of a malfunction having occurred.The service provider hypothesized the end-user inadvertently activated the seat functions into an anterior tilt, and this caused the end-user to lose positioning.As no claims or allegations were received of a product malfunction having occurred, and the device remaining fully operational after the event; permobil in unable to reach a determination as to cause of adverse event without speculation.The dhr was reviewed, and device was found to have met specification prior to distribution.
Event or Problem Description
Report received claiming the end-user was using their power wheelchair inside a roll in shower.Report claims during the showering activities, at some point the end-user lost their positioning and fell out of the seating to the shower floor where they reportedly 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: 15948935
• Report Number: 1221084-2022-00023
• Device Sequence Number: 17769877
• 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): 12/09/2022

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: 11/14/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2022
• 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