BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL M400 HD

    MDR report key: 15079219 · Received July 21, 2022

    Report

    Report Number
    1221084-2022-00013
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 30, 2022
    Report Date
    October 25, 2022
    Manufacturer
    PERMOBIL INC
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PERMOBIL AB WERE PROVIDED PHOTO EVIDENCE OF THE DEVICE WHEN THE EVENT OCCURRED. PHOTOS CONFIRMED THE SEATING SYSTEM HAVING DETACHED FROM THE CHASSIS. PHOTOS APPEAR TO INDICATE A MATERIAL BREAK HAVING OCCURRED WHERE THE SPLINE PORTION OF THE ELEVATOR IS ATTACHED TO THE MOUNTING PLATE WHICH SECURES THE SEATING. PERMOBIL AB HAS REQUESTED THE SUSPECT COMPONENT BE RETURNED TO PERMOBIL AB FOR FURTHER ANALYSIS IN EFFORT TO DETERMINE POTENTIAL ROOT CAUSE FOR THE FAILURE. REVIEW OF COMPLAINT DATA INDICATES THIS TO BE THE FIRST REPORTED FAILURE OF THIS TYPE. UPON 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.

    Additional Manufacturer Narrative · 0

    PERMOBIL AB SENT THE FAILED COMPONENT TO AN EXTERNAL COMPANY THAT CARRIED OUT A MATERIAL AND FAILURE ANALYSIS. REPORT RESULTS INDICATED THE CAUSE OF THE COMPONENT FAILURE WAS MATERIAL FATIGUE WHICH ORIGINATED FROM FAILURE TO FULLY BOND DURING THE WELDING PROCESS. THE FATIGUE FAILURE WAS STARTED AT SEVERAL POINTS AT BOND FAILURE, WHERE THE CRACKS HAVE GROWN THE SAME AND CONTINUED UNTIL THE REMAINING SURFACE COULD NOT COPE WITH THE LOAD, WHICH FINALLY RESULTED IN A RESIDUAL FAILURE. REVIEW OF COMPLAINT DATA INDICATES THIS TO BE THE FIRST REPORTED FAILURE OF THIS TYPE SINCE THE IMPLEMENTATION OF THIS COMPONENT INTO THE MARKET IN 2013. PERMOBIL WILL CONTINUE TO MONITOR ANY SIMILAR FAILURES THROUGH TREND ANALYSIS.

    Description of Event or Problem · 0

    PERMOBIL AB RECEIVED REPORT CLAIMING AS THE END-USER WAS DRIVING ALONG A SIDEWALK, THE SEATING WAS REPORTED TO HAVE DETACHED FROM THE CHASSIS WHICH RESULTED IN THE END-USER FALLING TO THE GROUND. NO INJURIES WERE REPORTED TO HAVE OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89489 PERMOBIL M400 HD POWER WHEELCHAIR ITI PERMOBIL INC M400 HD N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose