MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL C350; POWERED WHEELCHAIR

Model Number C350

Device Problem Fracture (1260)

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

Event Date 05/17/2019

Event Type  malfunction  

Manufacturer Narrative

During a routine service evaluation, it was noted cracks were forming in the material of the top plate to which the seating system attaches on the fixed seat tube.It was noted the top plate did not detach from the inner tube, but the potential for possible detachment was noted.The component failure is being attributed to stresses being applied over time leading to eventual material fatigue of the top plate.A corrective and preventative action (capa (b)(4)) has been implemented to investigate, correct, and monitor effectiveness.As a result of the capa investigation, it was decided that a thicker 8mm material be used for the top plate, replacing the current 6mm design.With this material design change, it was determined the change to the thicker material improved the overall strength of the component making it less susceptible to material fatigue when exposed to log term stresses.The redesigned component has been supplied to the service provider, installed on the device, and the chair returned to the end-user.The dhr was reviewed and chair met specification prior to distribution.

Event Description

Received report from service provider as they were performing a routine service inspection, they noticed cracks forming on the top plate of the fixed seat tube around the area where the weld secures it to the inner tube.Reports indicate the top plate did not detach and the end-user did not suffer any injuries as a result.

• Brand Name: PERMOBIL C350
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB); per uddens vag 13; timra, 86102 3; SW 861023
• Manufacturer (Section G): PERMOBIL AB; per uddens vag 20; timra, 861 2 3; SW 861 23
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 8682464
• MDR Text Key: 147469296
• Report Number: 1221084-2019-00026
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K071650
• 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: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C350
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/03/2011
• 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