MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL C500; POWER WHEELCHAIR

Model Number C500

Device Problems Mechanical Problem (1384); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Manufacturer Narrative

Reports claim the end-user had placed the device into stand and was in that position for approximately 5 minutes when the device allegedly tipped over forward causing the end-user to fall forward to the ground.Reports state the end-user was not injured as a result of the fall.The device was inspected the following day by the service provider who could not find any issues with the device.The device was reported to have been fully operational both with and without an occupant in the seating.Full operational tests were performed with the end-user to verify they were using the device as intended and the support wheels were deploying as designed.The seating system is incorporated with support wheels to where when transitioning into the stood position, the wheels will deploy and contact the ground to support the end-user while stood.Caregivers at the scene could not recall if the support wheels were making contact with the ground prior to the event occurring.All subsequent tests of the device shown the standing function to be fully operational with the support wheels deploying each time.It remains unclear as to why the device fell forward as the device was fully functional and alleged failure could not be reproduced.Caregivers were instructed to be vigilant in ensuring the support wheels are in contact with the ground when using the stand feature.The dhr was reviewed and device met specification prior to distribution.

Event Description

Received reports claiming as end-user was in their living room using the device in the stood position; the device allegedly tipped forward, causing the device, with end-user, to fall forward to the ground.Reports indicate the end-user was not injured during the event.

• Brand Name: PERMOBIL C500
• Type of Device: POWER WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• Manufacturer (Section G): PERMOBIL INC.; 300 duke dr.; lebanon TN 37090
• Manufacturer Contact: kevin bullock ; 300 duke dr.; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 8641301
• MDR Text Key: 146493685
• Report Number: 1221084-2019-00020
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991658
• 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: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C500
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2014
• 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 Weight: 120