BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER ELITE

    MDR report key: 3040613 · Received March 14, 2013

    Report

    Report Number
    2020362-2013-00120
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Report Date
    February 19, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - THE REPORTED PRODUCT ISSUE WAS CONFIRMED. EVALUATION REVEALED THAT THE UNIT POWERS UP, BUT THE ALARM DOES NOT SOUND WHEN THE MAGNET IS REMOVED FROM THE MAGNET PLATE. THE ALARM DOES SOUND WHEN USING A WORKING SENSOR PAD AND WEIGHT IS REMOVED FROM THE SENSOR. THE UNIT DID NOT PASS FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE WARNING STATES: IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED. THE PIR SENSOR IS ACTIVATED, OR MAGNET IS REMOVED FROM THE FACE PLATE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM HAS POWER AND FLASHES THE GREEN LIGHT. HOWEVER, WHEN THE MAGNET PULL CORD IS DETACHED FROM THE ALARM IT DOES NOT SOUND. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM REPORTED. THE REPORTED ISSUE WAS DISCOVERED DURING SETUP THE DATE WAS NOT PROVIDED. THERE WAS NO PT CONTACT AND NO INCIDENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108159 POSEY SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MAGNET: MODEL 8345M