MAUDE Adverse Event Report: PERMOBIL AB (PAB) PERMOBIL F3; POWERED WHEELCHAIR

Model Number F3

Device Problem Insufficient Information (3190)

Patient Problems Abrasion (1689); Easy Bruising (4558)

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Information provided to permobil claims as the end-user was driving their device at full speed, the device came to a sudden stop.Reports indicate the end-user was not wearing their positioning belt at the time and when the stoppage occurred, caught the end-user off guard allowing them to lose positioning and fall forward out of the seating after the sudden loss of forward momentum, reports indicate the end-user sustained some minor abrasions to their hands and some minor bruising, neither of which required medical intervention.The wheelchair was inspected and evaluated by permobil technicians who determined the cause of the reported abrupt stoppage being a loose cable connection in the r-net drive control electronics.When the interruption in the connection occurred, it caused a loss of signal in the electronics forcing the device to come to a controlled stop.Reports indicate prior to the event, the device had been previously serviced for a similar issue with the r-net bus cable, but no components were replaced at that time as no issues could be identified.Permobil was unable to identify a technical root cause for the loose connection but is considering the possibility the previous service activities may have contributed.Although no specific component failure could be identified, out of an abundance of caution, the r-net cable and connection was replaced, and device returned to the end-user with no further issues being reported.The dhr was reviewed and the device was found to have met specification prior to distribution.

Event Description

Received report indicating while the end-user was driving outdoors, at speed, the device reportedly made an abrupt stop causing the end-user to lose positioning and fall out of the seating to the ground.The end-user was reported to have not sustained any injuries that necessitated medical intervention.

• Brand Name: PERMOBIL F3
• 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 86123
• Manufacturer Contact: kevin bullock ; 300 duke drive; lebanon, TN 37090 ; 8007360925
• MDR Report Key: 11731822
• MDR Text Key: 250252504
• Report Number: 1221084-2021-00015
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K143180
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: F3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2018
• 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