BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE FALL MONITOR

    MDR report key: 3181749 · Received June 6, 2013

    Report

    Report Number
    2020362-2013-00251
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION AND HAS NOT BEEN RECEIVED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DOES NOT SOUND WHEN WEIGHT IS LIFTED FROM THE SENSOR. CUSTOMER HAS TESTED THE SENSOR WITH A KNOWN WORKING ALARM AND THE SENSOR FUNCTIONS PROPERLY. CUSTOMER DID NOT PROVIDE A DATE WHEN DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252052 KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER MATTRESS SENSOR PART #8307, LOT #UNK