BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3922119 · Received May 30, 2014

    Report

    Report Number
    2020362-2014-00208
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE OF NO SOUND. THE UNIT SOUNDS AND SENDS SIGNAL TO THE NURSE CALL TEST FIXTURE WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD; HOWEVER, IF THE SENSOR CABLE IS MOVED, THE UNIT SOUNDS ON AND OFF AND AT THE SAME TIME THE SIGNAL ON THE NURSE CALL TEST FIXTURE COMES ON AND OFF. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTING. ALL PINS INSIDE THE SENSOR RECEPTACLE ARE BENT DOWN AND THE UNIT HAS BEEN EXPOSED TO MOISTURE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE ALARM IS IN USE WITH THE NURSE CALL CABLE, THE ALARM DOES NOT SOUND. ISSUE WAS DISCOVERED DURING SET-UP BUT THE DATE IS UNKNOWN. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320039 KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NURSE CALL CABLE PART # 8282, LOT # UNK