MAUDE Adverse Event Report: PERMOBIL INC. PERMOBIL M300; POWERED WHEELCHAIR

Model Number M300

Device Problem Break (1069)

Patient Problem Discomfort (2330)

Event Type  malfunction  

Manufacturer Narrative

Investigation revealed the root cause of this failure mode is linked to a "component failure".The patient was occupying the wheelchair when the slewing bracket broke.As a result, the backrest assembly gave way and the patient reported falling out of the seat.The patient did not seek medical attention at this time because no injuries were sustained.The patient indicated seeking medical attention 2 years later from which the mri test results came back negative not showing any damage.The suspect wheelchair was evaluated, and failure mode confirmed.This is a known component problem linked to a capa that has been redesigned with stronger material to prevent reoccurring failures subject to long-term stress and fatigue.The patient having been dissatisfied with the suspect wheelchair received a replacement device.The suspect wheelchair was repaired with a new component and no further malfunctions have been reported to occur for either device.The dhr for this device was reviewed and the wheelchair met specification prior to distribution.Note: this is a late filing mdr that is a direct result of an exercise to improve our qms from a capa.This action is to ensure that all reportable complaints connected to a confirmed malfunction linked to an adverse event are properly submitted.Due to the age of the complaint and lack of communication from patient, specific details related to the event are unavailable.Please reference the attached cover letter: "permobil retroactive mdr filing (1 of 5).".

Event Description

Patient reported that his backrest broke and threw him out of the seating system.He did not report any injuries that require medical attention.Patient indicated he was suffering from a sore shoulder.

• Brand Name: PERMOBIL M300
• 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: shawn waynick ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 9406530
• MDR Text Key: 184120635
• Report Number: 1221084-2019-00053
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: M300
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/20/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2012
• 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