BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 5932857 · Received September 7, 2016

    Report

    Report Number
    9681423-2016-00010
    Event Type
    Malfunction
    Date Received
    September 7, 2016
    Date of Event
    August 5, 2016
    Report Date
    October 4, 2016
    Manufacturer
    N/A
    Product Code
    FSA
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED ON 9/12/2016 BY THE MANUFACTURER (COMPASS HEALTH BRANDS). THE UNIT WAS VISUALLY INSPECTED, AND FOUND TO HAVE NO CRACKED/BREAKS IN THE PLASTIC, AND THE PISTON'S METAL PIN AND TEETH ARE NOT WORN/BROKEN. THE CUSTOMER STATED THAT THE UNIT'S WEIGHT SETTING WENT FROM 99 LBS. (REALLY 95 LBS.) TO 200 LBS. THIS ACTION WOULD BE IMPOSSIBLE, UNLESS SOMEONE CHANGED THE SETTINGS INTENTIONALLY. THE PISTON HAS CONSISTENT PRESSURE ON THE TEETH THAT PREVENT IT FROM FALLING OUT OF PLACE. IF THE PISTON DID EVER COME LOOSE, IT ACTUALLY WOULD DECREASE THE WEIGHT SETTING, OR NOT ENGAGE IN THE TEETH, AND THE SEAT WOULD NOT LIFT AT ALL. IF THE SEAT IS PULLED AWAY FROM THE TEETH, THE PISTON JUST FALLS DOWN, AND WILL NOT ENGAGE UNLESS THE END-USER RE-INSTALLS IT INTO THE CORRECT WEIGHT SETTING. THIS COMPLAINT ABOUT THE SEAT POPPING UP, AND THE END-USER FALLING OFF, MAY HAVE BEEN DUE TO NOT HAVING THE SEAT ON THE CORRECT WEIGHT SETTING (TO HIGH), AND MAY HAVE LEAD IT TO POP UP. THE DEVICE'S SERIAL NUMBER WAS ABLE TO BE READ UPON RETURN ((B)(4)).

    Description of Event or Problem · 1

    THE CONSUMER CALL IN ON BEHALF OF HIS MOTHER. SHE HAS DEMENTIA, AND USES THE LIFTING SEAT TO HELP GET OUT OF A CHAIR. THE USER IS (B)(6) LBS., AND LIVES WITH HER SON. SHE IS (B)(6) YEARS OLD. PER THE END-USER'S SON, THE UNIT IS CHANGING WEIGHT SETTINGS WITHOUT ANYONE DOING SO. IT WAS CHANGED TO THE SETTING OF 99 POUNDS, AND HIS MOM WAS SITTING ON IT, WHEN IT POPPED UP AND CAUSED HER TO FALL OFF A CHAIR. SHE FELL SLOWLY FROM THE CHAIR TO THE GROUND. AGAIN, PER HER SON, THE UNIT IS CHANGING WEIGHT SETTINGS WITHOUT ANYONE DOING SO. FOR EXAMPLE, WHEN SHE FELL, IT WAS AT 99 LBS., BUT WHILE LOOKING AT THE PRODUCT ON A LATER DATE, THE UNIT WAS SET AT 220 LBS. SHE WENT TO THE ER BY AMBULANCE WITHOUT ANY INJURIES. NO X-RAYS WERE PERFORMED AT THE ER, BUT THE DOCTOR CHECKED HER OUT AND SAID SHE WAS OK. THE EVENT HAD OCCURRED ON LAMINATE FLOORING AT THE END-USER'S HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584478 N/A N/A FSA N/A N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R