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

Model Number F5

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bone Fracture(s) (1870)

Event Date 03/01/2018

Event Type  Injury  

Manufacturer Narrative

Investigation revealed that the root cause of this failure mode is "improper use - device interface".Due to the patient's physical condition, the dealer modified the legrest assembly on the seating system to keep the patient's legs straight out in front when using the wheelchair.Prior to the incident, the patient reported that the wheelchair was experience erratic movement when operating in high speed.The dealer reported that they were in-process of fine tuning the programming speeds in an attempt to offer better steering controls for the patient with this type of custom modification.The dealer reported that they informed the patient to wait and not use the device until setup is completed.The patient elected to use the product "off label" against the dealer's recommendation and was driving full speed outdoors and impacted his leg against an object.The patient did not notice injury occurred until the following day and then sought medical attention.The patient had suffered from a fracture to the right leg.The wheelchair was evaluated, and no damages were sustained from the event.The product was tested, and no malfunctions or defects were discovered, as the device operated according to specification.The wheelchair was reprogrammed to give the patient a better sense of control.The patient was also cautioned to operate the device in a safe manner when in tight spaces or outdoors amongst other obstacles.The dhr for this device was reviewed and the wheelchair met specification prior to distribution.

Event Description

Reports are that the patient broke his leg because the wheelchair was driving erratically.Dealer reported that the product was under an evaluation prior to the incident and the patient was instructed to not use the device.The patient went against the dealer's warning and used the wheelchair.

• 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: shawn waynick ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 7393761
• MDR Text Key: 104223667
• Report Number: 1221084-2018-00021
• 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: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• 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: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2015
• 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
• Patient Weight: 82