BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY HOOK & LOOP ALARM BELT LONG

    MDR report key: 3888383 · Received April 16, 2014

    Report

    Report Number
    2020362-2014-00146
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Report Date
    January 31, 2014
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCTS REVEALED THAT WHEN THE ALARM WAS TESTED WITH A KNOWN WORKING SENSOR BELT, THE ALARM PASSED FUNCTIONAL TESTS PERFORMED. HOWEVER, WHEN THE ALARM WAS TESTED WITH THE RETURNED SENSOR BELT, THE ALARM TURNED ON/OFF WHEN THE BELT WAS MOVED. NO PHYSICAL DAMAGE WAS OBSERVED. THE RETURNED SENSOR BELT WAS RETESTED WITH A KNOWN WORKING ALARM, BUT THE RESULTS REMAIN THE SAME. THE TESTS REVEAL THAT THE SENSOR WIRES ARE BROKEN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER UNABLE TO PROVIDE ANY OTHER INFO THAN THE ALARM IS BROKEN. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN. NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233650 POSEY HOOK & LOOP ALARM BELT LONG KMI J. T. POSEY COMPANY 8372L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARM, MODEL # 8350, SN (B)(4)