MAUDE Adverse Event Report: PERMOBIL INC PERMOBIL M400 HD; POWER WHEELCHAIR

Model Number M400 HD

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/30/2022

Event Type  malfunction  

Manufacturer Narrative

Permobil ab were provided photo evidence of the device when the event occurred.Photos confirmed the seating system having detached from the chassis.Photos appear to indicate a material break having occurred where the spline portion of the elevator is attached to the mounting plate which secures the seating.Permobil ab has requested the suspect component be returned to permobil ab for further analysis in effort to determine potential root cause for the failure.Review of complaint data indicates this to be the first reported failure of this type.Upon receipt of any new information, a follow-up report will be submitted.The dhr was reviewed, and the device was found to have met specification prior to distribution.

Event Description

Permobil ab received report claiming as the end-user was driving along a sidewalk, the seating was reported to have detached from the chassis which resulted in the end-user falling to the ground.No injuries were reported to have occurred as a result.

Manufacturer Narrative

Permobil ab sent the failed component to an external company that carried out a material and failure analysis.Report results indicated the cause of the component failure was material fatigue which originated from failure to fully bond during the welding process.The fatigue failure was started at several points at bond failure, where the cracks have grown the same and continued until the remaining surface could not cope with the load, which finally resulted in a residual failure.Review of complaint data indicates this to be the first reported failure of this type since the implementation of this component into the market in 2013.Permobil will continue to monitor any similar failures through trend analysis.

• Brand Name: PERMOBIL M400 HD
• Type of Device: POWER 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 dr.; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 15079219
• MDR Text Key: 304339341
• Report Number: 1221084-2022-00013
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K123290
• 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,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M400 HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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 Sex: Prefer Not To Disclose