MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL F5; POWERED WHEELCHAIR

Model Number	F5
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation revealed that the root cause of this failure mode is contributed to "component failure".While the patient was in the wheelchair the left side drive wheel detached from the device.The patient was not injured in the event.The wheelchair was evaluated and the main hub bolt loosened and backed out, allowing the drive wheel to slide off the drive motor shaft.This is a known issue that has since been corrected.The failure was linked back to the supplier and related to an assembly error installing the wheel hub to the drive motor shaft.The risk for this failure to occur is low and the likely hood of injury to occur is also very low.Due to this known repeat failure mode, a capa has been opened by our parent company.Upon completion of the capa, if further corrective action is required for this wheelchair this case will be re-opened and a follow-up mdr will be submitted.The spare parts necessary for the repair have been supplied and the wheelchair repaired and returned to the patient.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
Event or Problem Description
Reports that the left drive wheel assembly detached from the wheelchair.It was discovered that the main hub bolt had backed out.No injuries have occurred.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 7905143
• Report Number: 1221084-2018-00057
• Device Sequence Number: 13905041
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: F5
• 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: 09/04/2018
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68