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

Model Number F5

Device Problems Mechanical Problem (1384); Unintended Collision (1429); Unintended Movement (3026)

Patient Problem Bruise/Contusion (1754)

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device was conducted by permobil representatives where the co-pilot attendant control was sporadic in operation, often not engaging a drive command when squeezing the handle.Inspection of the co-pilot control shown signs of impacts to the switch handle and sensor housing.Further inspection found the sensor was slightly out of adjustment, but after repositioning the sporadic non-engaging remained.It was noted that throughout the operational testing, the device never continued to operate when the switch handle was released, nor accelerate uncontrollably when the switch handle was depressed as reported to have occurred.Permobil has concluded the sporadic operation of the co-pilot control as being attributed to damages to the internal components, caused by repeated impacts.It remains unclear if the damages were caused by improper use from the attendant and/or inadvertent impacts by the end-user.The affected co-pilot control is being replaced with new and device to be returned to the end-user.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Received report from provider claiming the staff at clients group home attempted to move the device with the co-pilot attendant control and upon engaging, the device allegedly accelerated and continued to drive even after releasing the handle.Device reportedly drove into the bed where the end-user sustained minor injuries consisting of a few bruises.

• 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: 11585626
• MDR Text Key: 256799305
• Report Number: 1221084-2021-00008
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K143180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 02/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 91