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

Model Number	F5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	07/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Permobil received report of the end-user having to be admitted into the hospital due to developing a pressure wound requiring medical intervention to address.Reports claim a component on the device had malfunctioned which would not allow the end-user to manipulate the seating into a tilted position to allow for pressure relief.The end-user continued to utilize the device in this state until the damaged component could be replaced.Due to logistical issues, the component was not shipped in a timely manner and due to the inability to weight shift, the end-user reportedly developed a pressure ulcer.At this time permobil has not determined the root cause for the component failure but has determined the failure in and of itself was not the cause of the reported adverse event.Once permobil has received any new information as to cause of failure, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.
Event or Problem Description
Received report claiming due to the inability to replace defective component on the wheelchair in a timely manner, the end-user developed a pressure ulcer requiring hospitalization to address.
Additional Manufacturer Narrative
Service provider reports having replaced the ap unit, and the device has been returned to the end-user with no further reported issues.Provider claims the suspect component had been discarded as they were unaware that permobil was wanting the component back for inspection.Provider described the issue as being that of the inability to perform a tilt or elevate with a 20ca seat lift error (node is required but not present).With testimony received from provider, permobil believes a failure occurred, but as suspect component had been discarded prior to evaluation, permobil is unable confirm root cause for failure without speculation.It is permobil's contention that the reported component failure in and of itself was not the cause of the adverse event, but rather the end-user continuing use of the device in a diminished state without the ability to perform adequate weight shifts.

• Brand Name: PERMOBIL F5
• 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: 15329226
• Report Number: 1221084-2022-00016
• Device Sequence Number: 6361173
• 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
• 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): 10/21/2022

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: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2018
• 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