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	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation revealed that the root cause of this failure mode is contributed to "component failure".The patient was using the wheelchair outdoors when the left drive wheel assembly detached from the device.The patient was not injured in the event.An evaluation of the product confirmed the complaint and the main hub bolt had sheared off, allowing the drive wheel and hub assembly to detach itself from the motor shaft.The patient reported having the wheelchair repaired by an unauthorized technician.The owner's manual warns uses to not allow unauthorized work to be done to the wheelchair, as we are unable to guarantee the quality of workmanship or training of other individuals.The patient has been informed that unauthorized repairs are not allowed and to only use a certified dealer going forward.A permobil certified servicing dealer has reassessed the wheelchair and performed necessary corrections to ensure the device is operating according to specification.The risk analysis shows the risk to the patient to be very low.Due to this known repeat failure mode, a capa has been opened for this failure 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 suspect wheelchair was repaired and returned to the customer assembled according to specification.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
Event or Problem Description
On (b)(6), the end user was on a morning drive with her wheelchair, when the front left drive tire detached from the chassis.No injury was reported to 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: 7573423
• Report Number: 1221084-2018-00038
• Device Sequence Number: 1698693
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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,consum
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66