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

Model Number M3

Device Problems Mechanical Problem (1384); Structural Problem (2506)

Patient Problem Embolus (1830)

Event Date 05/04/2020

Event Type  Injury  

Manufacturer Narrative

Permobil was contacted by end-users mother reporting the seating system on device has a continuous lean to one side for which the service provider has been unable to resolve.Report claimed this causes the inability for the end-user to maintain proper body positioning in the seating.It was alleged due to the end-users inability to sit up straight, formation of blood clots in the lungs occurred requiring the end-user to be hospitalized.Permobil canada was contacted by service provider and an inspection of the device was performed on 6/30/2020.Inspection confirmed the seating not being level where it was determined the ap unit, which the seating is attached, having side/side movement that was considered more excessive than normal.The device was found to be fully operational, although was confirmed the end-user is leaning more to one side.It remains unclear if the excessive leaning of the seating was initiated by premature component wear or if component wear was the result of the end-users positioning in the seating allowing them to lean to one side.Service provider has been supplied with a replacement ap unit to install on the device.Permobil has recommended the end-user be reassessed for their positioning needs in effort to provide adequate support to ensure the end-user is properly positioned in the seating to prevent the propensity to lean to one side.The dhr has been reviewed and the wheelchair was found to have met specification prior to distribution.

Event Description

Received report claiming the wheelchairs seating system is leaning so much to the right side that it has caused physical complications, allegedly leading to pulmonary issues requiring hospitalization.

• Brand Name: PERMOBIL M3
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL INC.; 300 duke drive; lebanon, tn
• Manufacturer (Section G): PERMOBIL INC.; 300 duke drive; lebanon, tn
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, tn ; 7360925451
• MDR Report Key: 10448948
• MDR Text Key: 204233053
• Report Number: 1221084-2020-00041
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 17330818345674
• UDI-Public: 17330818345674
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• 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 Outcome(s): Hospitalization
• Patient Weight: 109