BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARINO

    MDR report key: 4181110 · Received October 14, 2014

    Report

    Report Number
    3007420694-2014-00099
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH (B)(4). ON BEHALF OF THE (B)(4). THIS APPEARS TO BE A "MALFUNCTION" TYPE OF EVENT NOT BECAUSE THERE WAS A TECHNICAL MALFUNCTION OF THE DEVICE, BUT SINCE DUE TO A USE ERROR THE DEVICE DID NOT PERFORM AS INTENDED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE; PATIENT WAS BEING SHOWERED IN CARINO CHAIR, AID WAS PUSHING PATIENT OUT OF SHOWER INTO MAIN BATHROOM AREA, WHEN CHAIR STARTED TO HIT TRANSITION (LIP ON SHOWER STALL) FROM THE SHOWER STALL TO BATHROOM FLOOR THE FRONT WHEELS GOT STUCK IN TRANSITION (LIP ON SHOWER STALL) AND CARINO CHAIR FLIPPED FORWARD, PATIENT FELL ON FLOOR. AID THEN USED A PASSIVE LIFT AND LIFTED PATIENT OFF FLOOR AND PUT DIRECTLY INTO HER BED UNTIL SHE WAS ABLE TO BE EXAMINED BY NURSE. AID SAID THE RIGHT FRONT WHEEL WOULD NOT PIVOT CORRECTLY AND WAS SIDEWAYS ON TRANSITION POINT FROM SHOWER STALL TO BATHROOM FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650038 CARINO FSA ARJOHUNTLEIGH POLSKA SP. ZO.O. BOC1003-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other