BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 2191782 · Received July 28, 2011

    Report

    Report Number
    2020362-2011-00236
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    June 28, 2011
    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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL : RESULTS: EVAL OF THE RETURNED PRODUCT SHOWS THAT WHEN TESTED USING A WORKING SENSOR, THE ALARM POWERS ON, BUT DOES NOT SOUND THE ALARM WHEN WEIGHT IS REMOVED FROM THE SENSOR. ALSO, THE FAIL SAFE AND TONE SELECTOR FEATURES DO NOT WORK. THE ALARM DOES NOT PASS FUNCTIONAL TESTS. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER STATED THAT WHEN WEIGHT IS REMOVED FROM THE SENSOR, THE ALARM DOES NOT SOUND. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. ALSO, THE ALARM WAS TESTED WITH A NEW SENSOR AND THE RESULTS REMAIN THE SAME. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA OVER THE MATTRESS SENSOR PAD, MODEL# 8307| LOT# UNK