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

Model Number F5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fracture, Arm (2351); Tooth Fracture (2428)

Event Date 11/02/2017

Event Type  Injury  

Manufacturer Narrative

Testimony received by the dealer from the end-user's family claim; as the end-user was entering the lift platform, the device was maneuvered to close to the lift control panel.The claim was the joystick control on the device hit the lift panel which forced the end-user to push the js inductive forward causing the device to accelerate.When reaching the end of the platform, they claim the chair struck the safety barrier and continued to drive forward off the end.It was reported the device fell approximately 6 feet to the ground which result in the end-user suffering fractures to both left and right humerus bones and 2 broken teeth.A school surveillance video captured the entire event and appears to confirm the testimony presented by the family.Testimony taken from end-user and caregivers report the device was fully operational with no malfunctions being noted prior to the event occurrence.No allegations or reports have been made to permobil of any deviation with the device which may have attributed to this reported event.Service provider has attempted to repair the device by replacing components that were affected by the impact.Permobil became aware of the event only after the service provider requested the device be returned to permobil corporate for evaluation as attempts to repair were unsuccessful.Dealer claims having not notified permobil initially due to no allegations of the device having attributed to the event.The dealer was informed by letter that permobil recommends that the device be replaced as we can no longer guarantee the safety or continued performance of our product.Such an extraordinary event to a sophisticated medical device may create considerable damage that may be imperceptible during an inspection.The dhr was reviewed and device met specification prior to distribution.

Event Description

Received report claiming as end-user was entering a platform lift at their school, the end-user inadvertently accelerated, driving device off the end of the platform causing the chair, with end-user, to drop approximately 6 feet to the ground.It was reported the end-user suffered injuries which required medical intervention.

• Brand Name: PERMOBIL F5
• Type of Device: 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: 7370379
• MDR Text Key: 103462264
• Report Number: 1221084-2018-00020
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: F5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization