BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMP _ PERSONAL SENTRY

    MDR report key: 1348704 · Received February 6, 2006

    Report

    Report Number
    1348704
    Event Type
    Injury
    Date Received
    February 6, 2006
    Date of Event
    January 23, 2006
    Report Date
    January 24, 2006
    Manufacturer
    UNIVERSAL MEDICAL PRODUCTS, INC.
    Product Code
    OHN
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AT 09:30 PM, ALARM CLIPPED TO RESIDENT. CNA STATED SHE HAD NO REASON TO BELIEVE ALARM OR CLIP TO BE DEFECTIVE. AT 9:45 PM, RESIDENT FOUND IN ANOTHER RESIDENT'S ROOM ON FLOOR- HAD AMBULATED THERE INDEPENDENTLY. CLIP ALARM FOUND ON BED, UNCLIPPED FROM RESIDENT AND NOT SOUNDING. AT 10:15 PM, RESIDENT TRANSPORTED TO HOSPITAL WITH PROBABLE HIP FRACTURE. UPON ASSESSMENT OF ALARM AFTER FALL, CLIP FOUND TO BE BENT AND WHITE SAFETY TAPE IN DISREPAIR. CLIP WAS TESTED. COULD NOT CONSISTENTLY MAINTAIN SUBSTANTIAL GRIP ON MATERIAL WITHOUT SLIDING OFF TO PULL MAGNET AWAY FROM ALARM BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMP _ PERSONAL SENTRY PERSONAL CLIP ALARM OHN UNIVERSAL MEDICAL PRODUCTS, INC. PS-1

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Hospitalization