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

Model Number	M3
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	02/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Permobil received report claiming while end-user was operating their wheelchair to reposition, the backrest reportedly detached which caused the end-user to lose positioning and fall backwards out of the device seating to the ground.Report indicates the end-user was taken to local hospital for evaluation where they were diagnosed as having sustained a concussion.
Additional Manufacturer Narrative
Report claims as the end-user was in process of laying the seating back, it was reported the backrest detached from the seating allowing the end-user to fall back and strike their head on the ground resulting in a concussion.Inspection of the device was performed by service provider which indicated the hardware used to secure the backrest assembly to the hinges appear to have loosened over time and backed out.With the loss of hardware, the backrest lost the ability to maintain upright support and fell backwards.Photo evidence indicated the hardware (m6x14 and m6x30) bolts remain intact and free from damage which concluded the hardware having loosened as opposed to material failure.Service provider reports having re-installed the backrest with the existing hardware, operationally tested, and returned to the end-user.Service was completed by service provider and device returned to end-user prior to permobil representative being able to evaluate.Permobil will continue investigation in effort to determine possible root cause, and 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.
Additional Manufacturer Narrative
In effort to determine if there was a deviation in manufacturing processes, assembly instructions provided to the supplier were reviewed, verified, and confirmed to include proper torque values, for the hardware, as per design specifications.It was, however noted, there weren't any measures in place to verify these torque specifications were performed during the assembly process.In effort to mitigate the potential for human error, the supplier included a secondary verification in the assembly process to ensure the hardware's were torqued according to specification.An inspection of finished backrest assemblies was conducted at the supplier and was confirmed all assembled product on hand were assembled correctly and securing hardware's were torqued according to design specifications.Although unconfirmed, it is permobil's contention the hardware on the backrest assembly, for this specific unit, was not properly torqued from the supplier.Permobil will continue to monitor for this reported failure mode through trend analysis.

• 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: 13733347
• Report Number: 1221084-2022-00006
• Device Sequence Number: 17409113
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2022

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?: Yes
• 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: 02/15/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 05/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: Required Intervention; Hospitalization
• Patient Sex: Prefer Not To Disclose