BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL F5

    MDR report key: 7953553 · Received October 10, 2018

    Report

    Report Number
    1221084-2018-00065
    Event Type
    Malfunction
    Date Received
    October 10, 2018
    Date of Event
    September 13, 2018
    Report Date
    December 17, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K143014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION REVEALED THAT THE ROOT CAUSE OF THIS FAILURE MODE IS LINKED TO A "COMPONENT FAILURE". THE MAIN WHEEL HUB BOLT ON THE DRIVE MOTOR SNAPPED CAUSING THE LEFT DRIVE TIRE TO DETACH. THE PATIENT WAS NOT HARMED. CLIENT INFORMATION WAS MISSING IN THE PREVIOUS REPORT (GENDER, WEIGHT) AND NOW SUPPLIED. THE SERVICING DEALER HAS BEEN SUPPLIED THE SPARE PARTS NEEDED TO PERFORM THE REPAIR AND CORRECT THIS ISSUE. THE WHEELCHAIR HAS BEEN RETURNED TO PATIENT OPERATING ACCORDING TO SPECIFICATION. THE DHR FOR THIS DEVICE HAS BEEN REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL ACTIVE. CONFIRMED REPORTS ARE THAT THE MAIN HUB BOLT BROKE AND ONE OF THE DRIVE WHEEL DETACHED. THIS IS A KNOWN ISSUE THAT HAS SINCE BEEN CORRECTED. THE FAILURE WAS LINKED BACK TO THE SUPPLIER AND RELATED TO AN ASSEMBLY ERROR INSTALLING THE WHEEL HUB TO THE DRIVE MOTOR SHAFT. THE RISK FOR THIS FAILURE TO OCCUR IS LOW AND THE LIKELY HOOD OF INJURY TO OCCUR IS ALSO VERY LOW. WE HAVE MADE MULTIPLE ATTEMPTS TO COLLECT MORE INFORMATION SUCH AS PATIENT GENDER, WEIGHT, STATUS OF THE WHEELCHAIR AND WHETHER THE NECESSARY SPARE PARTS HAVE BEEN SUPPLIED TO THE DEALER. ONCE COMMUNICATION CAN BE ESTABLISHED AND CORRECTIVE ACTION IMPLEMENTED A FOLLOW-UP REPORT WILL BE SUBMITTED. ANY INFORMATION CURRENTLY MISSING IN THIS REPORT WILL BE INCLUDED IN THE SUPPLEMENT. THE DHR FOR THIS DEVICE HAS BEEN REVIEWED AND THE WHEELCHAIR MET SPECIFICATION PRIOR TO DISTRIBUTION.

    Description of Event or Problem · 1

    REPORTED WHEEL BOLT BROKE WHILE PATIENT WAS DRIVING. NO INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794383 PERMOBIL F5 POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) F5 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1