BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMOBIL M3 CORPUS

    MDR report key: 8111349 · Received November 28, 2018

    Report

    Report Number
    1221084-2018-00074
    Event Type
    Malfunction
    Date Received
    November 28, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 28, 2018
    Manufacturer
    PERMOBIL AB (PAB)
    Product Code
    ITI
    PMA / PMN Number
    K123290
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF EVENT INDICATES THE RECLINE ACTUATOR MOUNTING BRACKET HAVING BECOME DETACHED FROM THE SEAT FRAME TO WHICH IT ATTACHES VIA SECURING HARDWARE. INSPECTION INDICATES ONE OF THE 3 FASTENERS USED TO SECURE THE RECLINE MOUNTING BRACKET TO THE SEAT FRAME WAS NOT INSTALLED. THIS ALLOWED EXCESS FORCE TO BE APPLIED TO THE REMAINING 2 BOLTS LEADING TO EVENTUAL FATIGUE. INVESTIGATION REVEALED THAT THIS FAILURE MODE IS CONNECTED TO A PRODUCTION ERROR. DURING THE MANUFACTURING OF THE PRODUCT, IT HAS BEEN DISCOVERED THAT THE SUSPECT COMPONENT WAS INCOMPLETELY INSTALLED. PERMOBIL AB HAS IDENTIFIED THE POTENTIAL FOR THIS FAILURE AND HAS INCLUDED AN ADDITIONAL CHECK POINT IN THE PRODUCTION PROCESS TO ENSURE ANY FURTHER NONCONFORMITIES WILL BE CAPTURED PRIOR TO DISTRIBUTION. PERMOBIL AB CONDUCTED AN EVALUATION OF NON-CONFORMANCES ON THE PRODUCTION FLOOR AND POST-MARKET DATA AND HAVE DETERMINED THIS EVENT TO BE ISOLATED CASE. THE RECLINE ACTUATOR, MOUNTING BRACKET AND SECURING HARDWARE HAVE BEEN REPLACED WITH NEW; AS WELL AS OTHER COMPONENTS THAT WERE DAMAGED DURING THE IMPACT. DEVICE WAS RETURNED TO END-USER WITH NO FURTHER ISSUES HAVING BEEN NOTED.

    Description of Event or Problem · 1

    RECEIVED REPORT OF WHILE END-USER WAS USING THE TILT FEATURE FOR REPOSITIONING, THE BACKREST WAS REPORTED TO HAVE LOST SUPPORT ALLOWING THE END-USER TO FALL BACKWARDS. IT WAS REPORTED THE END-USER STRUCK THEIR HEAD ON SOME SHELVING THAT WAS BEHIND THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950597 PERMOBIL M3 CORPUS POWERED WHEELCHAIR ITI PERMOBIL AB (PAB) M3 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1