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

Model Number C500

Device Problems Misassembled (1398); Use of Device Problem (1670); Misassembly During Maintenance/Repair (4054)

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

Event Date 05/03/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that while end user was at their day program, using the stand feature of the device, the chair tipped forward while the end-user going up into standing.Reports indicate the end-user landed forward, in face down position, with chair behind them in standing position.End-user states tray kept them from being in contact with the ground and they were not injured during the event.End-user reports determining that the front support wheels did not go down to ground while chair was going up into stand.Stated the higher they went into stand, the chair tipped forward.End-user reported the day prior to the event, service had been performed where the dealer replaced the master module that controls seat functions.End-user stated after they replaced it, they did not use the stand function until the following day and that is when the event occurred.The service provider was contacted and it was reported after they evaluated the device, it was discovered the technician failed to reprogram the stand sequence in the new master module to meet the end-user's seating configuration.The program file permobil provides for standers is generic in that they are set to a standard elevator height for all devices.Upon the issuance of a new master module, the device requires the stand sequence to be re-programmed to meets the end-users specific seat configuration.The device was re-programmed to the correct position and the stand function was operational tested multiple times without any deviations.Device was returned to the end-user with no further issues being noted.The dhr was reviewed and device met specification prior to distribution.

Event Description

Received reports claiming as end-user was in process of raising the device into the standing 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: 8642316
• MDR Text Key: 146493156
• Report Number: 1221084-2019-00021
• 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: 05/14/2019
• 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: 81