BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE HEAVY DUTY

    MDR report key: 7705796 · Received July 20, 2018

    Report

    Report Number
    3004153586-2018-00001
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    May 5, 2018
    Report Date
    July 17, 2018
    Manufacturer
    HARMAR MOBILITY, LLC
    Product Code
    PCD
    UDI-DI
    00817650022395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF PRODUCT PERFORMANCE ISSUE HAS NOT BEEN REPORTED PREVIOUSLY. DURING THE ON-SITE INCIDENT INVESTIGATION, SEVERAL SCREWS THAT CONNECT THE CHASSIS MOTOR TO THE FRAME WERE FOUND TO BE LOOSE OR MISSING. THE UNIT WAS SENT TO HARMAR FOR FURTHER INVESTIGATION IN MAY WHERE IT WAS DETERMINED THAT THE SCREWS WERE LOOSE OR MISSING DUE TO THE LACK OF LOCTITE THREADLOCKER APPLICATION ON THE SCREWS.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE USER GOT ON THE STAIR LIFT CHAIR AT THE BOTTOM STEP AND WAS RIDING UPWARDS TO THE TOP LANDING WHEN THE STAIR LIFT MADE A POPPING SOUND AND THE STAIR LIFT SEAT/CHASSIS DESCENDED BACK DOWN THE STAIRCASE TO THE END OF THE RAIL. THE USER STEPPED OFF THE STAIR LIFT AS IT DESCENDED AND SUSTAINED MINOR PAIN IN HER LEG AND A SMALL CUT ON HER FINGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547756 PINNACLE HEAVY DUTY POWERED STAIRWAY CHAIR LIFT PCD HARMAR MOBILITY, LLC SL600HD 00817650022395

    Patients

    Seq Age Sex Outcome Treatment
    1