MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M3; POWERED WHEELCHAIR

Model Number M3

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

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

Event Date 02/09/2021

Event Type  malfunction  

Manufacturer Narrative

Inspection indicates a weldment point on the recline actuator mounting bracket having broken away.This weldment is where the recline actuator is secured, and in whole, is attached to the seat frame.It was reported when this component broke, it allowed the back hinge to no longer remain upright as the recline actuator was no longer secured.No serious injuries that necessitated medical intervention were reported as a result of this event.This is a known failure mode and following an investigation, permobil concluded no unusual or significant deterioration of the components were detected.To assess the full impact of this failure mode, capa (b)(4) has been opened to further investigate, correct and monitor effectiveness.The recline actuator and suspect bracket met acceptable performance margins and replacement components were approved for distribution.The service provider was supplied with the approved parts in order the repair of the device and return to the end-user.The dhr for this device has been reviewed and the wheelchair met specification prior to distribution.

Event Description

Received report claiming as the end-user was repostioning the seating, the backrest reportedly gave way allowing the end-user fall back to a prone position.No reports of injuries as a result.

• Brand Name: PERMOBIL M3
• 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: 11401634
• MDR Text Key: 241817189
• Report Number: 1221084-2021-00006
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2017
• 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: 113