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

Model Number	F5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation revealed that the root cause of this failure mode is linked to "improper user - device interface".The patient had been approved to have a standing power wheelchair by healthcare professionals.The patient has been demonstrating the use of stand for at least 7 years.During setup and initial use of stand on the suspect wheelchair, unknowingly the patient may have broken her right leg.There were no indications that injury had occurred during delivery and initial usage of the new wheelchair.The following day, reports received stated that the patient's femur was broke and is believed to have occurred after delivery.The wheelchair was evaluated and operating according to specification and no defects were identified.The patient's injury is seen as related to the patient's medical condition, even after being approved for a standing power wheelchair.The servicing dealer and the patient's doctors are reevaluating the patient for stand usage.Until cleared, the wheelchair's stand feature will be disabled and not operational.The decision to reactive stand is left between the dealer and patient's doctors.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.
Event or Problem Description
On (b)(6), the wheelchair was delivered to the customer.During setup and initial use of the stand feature the patient was allegedly injured.The following day the patient when to the hospital where broken right femur bone was confirmed.

• Brand Name: PERMOBIL F5
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon TN 37090
• MDR Report Key: 7202373
• Report Number: 1221084-2018-00005
• Device Sequence Number: 1357254
• Product Code: ITI
• UDI-Device Identifier: 17330818229844
• UDI-Public: 17330818229844
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K143014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/17/2018

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?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/17/2018
• 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: 75