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

Model Number	F5 VS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The end-user had contacted the dealer reporting the injury having occurred the day following initial delivery and set-up.It was reported that after the dealer had left, the end-user remained in the device but did not utilize the stand function.That evening while being transferred out of device and into bed, it was reported their left knee was swollen and was painful.The following day after noting the swelling in the knee had not subsided, they were taken to the hospital for evaluation.X-ray's were reported to indicate a fracture having occurred at the lower part of the left femur, just above the patella.The permobil territory manager and dealer, both of which were present at initial delivery, report the end-user never made mention of being uncomfortable or being in pain during the set up process.Territory manager reported after having covered operational characteristics of the device and setting seating for client positioning, an initial stand function was performed.Approximately half way into the initial stand sequence, it was noted the kneeblock assembly was getting tight against the end-users legs and their lower body had shifted to the side of the seating.When this was noticed, the end-user was informed to stop the stand sequence and lower the seating to a sitting position in order to make minor adjustments for proper positioning.After adjustments had been made, further stand sequences were performed all the while watching the end-users positioning and inquiring as to their physical well-being to which they claimed felling great.It is unclear as to when the reported injury may have occurred.The device is fully operational and remains in the end-user possession for mobility, but they are not using the stand function until having healed from the injury and receiving approval from their physician to resume standing therapy.The dhr was reviewed and the device met specification prior to distribution.
Event or Problem Description
Received report of the end-user having suffered an injury to their left leg reportedly after use of the stand function during initial delivery.

• Brand Name: PERMOBIL F5 CORPUS VS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 9535054
• Report Number: 1221084-2019-00066
• Device Sequence Number: 3337848
• Product Code: ITI
• UDI-Device Identifier: 17330818001006
• UDI-Public: 17330818001006
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K191874
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2019

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 VS
• 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: 12/10/2019
• Initial Report FDA Received Date: 12/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 77