BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POSEY 8350 KEEPSAFE ALARM

    MDR report key: 1091846 · Received July 31, 2008

    Report

    Report Number
    2020362-2008-00005
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 5, 2008
    Report Date
    July 10, 2008
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A POSEY COMPANY REP VISITED THE SITE AND CONFIRMED THAT THE YELLOW WIRE IN THE CABLE OF THE SENSOR PAD WAS BROKEN AND WAS EXPOSED. THE CUSTOMER DECLINED TO RETURN THE PRODUCT INVOLVED IN THE EVENT FOR FURTHER EVALUATION OF POSSIBLE ADDITIONAL WIRE DAMAGE. THE LABELING REQUIRES THAT THE ALARM AND SENSOR PAD BE TESTED PRIOR TO USE WITH A PT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PT ATTEMPTED TO GET UP TO GO TO THE BATHROOM. THE PT FELL ON THE SIDE OF THE BED AND BROKE HIS HIP. THE CUSTOMER STATED THE ALARM NEVER WENT OFF TO ALERT THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY 8350 KEEPSAFE ALARM KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention| S