MAUDE Adverse Event Report: PERMOBIL AB (PAB PERMOBIL M5; POWERED WHEELCHAIR

Model Number M5

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/09/2021

Event Type  Death  

Manufacturer Narrative

Permobil has not been able to reach a determination if a device malfunction may have contributed to the reported event.Permobil has been unable to perform any kind of inspection of the wheelchair at this early stage but is urgently seeking access in order to perform a technical examination.At this time, the device is being returned to permobil france to undergo a thorough inspection.Upon the completion of device evaluation, or upon the 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 of the end-user being found deceased at his home by an attendant that had come to his home to help him to go to bed for the night.Report indicated the end-user was found squeezed in between the wheelchairs seat unit and a computer desk, with the desk reportedly pressing against the end-user's diaphragm.

Manufacturer Narrative

The device was inspected by permobil technicians who were unable to detect any kind of malfunction or deviation in operation having occurred with the wheelchair, only minor physical damages that are being attributed to the impact sustained during the incident.The error log in the drive electronics was evaluated and nothing was found to be seen outside of normal conditions.The service provider reports the end-user was diagnosed as suffering from athetoid cerebral palsy which has the potential to create involuntary body movements, especially when trying to perform acts of free will.Root cause for this incident is not known, however evidence points to a possible use error scenario, where the user driving the wheelchair towards the computer desk in a speed high enough to cause impact to the desk resulting in the right armrest of the seat unit to push upwards (where joystick control is attached).This was also confirmed to be the final resting position of the wheelchair when the user was discovered.In this case permobil determined that there is no technical malfunction to the product that might have caused the incident to happen.The actual root cause is not possible to establish as the acts performed by the user cannot be confirmed, only be the most probable cause to the incident based on the facts received during the investigation.

• Brand Name: PERMOBIL M5
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PERMOBIL AB (PAB; per uddens vag 13; timra, 861 3 6; SW 861 36
• MDR Report Key: 11837668
• MDR Text Key: 251091428
• Report Number: 1221084-2021-00020
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• PMA/PMN Number: K123290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M5
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death