BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 4076391 · Received June 23, 2014

    Report

    Report Number
    2020362-2014-00226
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Report Date
    May 23, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED UNIT FOUND THAT THE UNIT DOES NOT SOUND INTERMITTENTLY ON ITS OWN WHEN IN USE WITH THE SENSOR PAD. THE UNIT IS SILENT WHEN WEIGHT IS APPLIED TO THE SENOR PAD, AND THE UNIT SOUNDS WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. HOWEVER, THE UNIT SOUNDS ON AND OFF WHEN THE SENSOR CABLE IS WIGGLED. THE UNIT PASSED ALL OTHER FUNCTIONAL TESTING. THE UNIT HAS BEEN EXPOSED TO MOISTURE AND ALL PINS INSIDE THE SENSOR RECEPTACLE ARE BENT DOWN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM SOUNDS INTERMITTENTLY WHEN IN USE WITH THE SENSOR. ISSUE WAS DISCOVERED DURING SET-UP, BUT DATE WHEN FOUND WAS NOT PROVIDED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364937 POSEY KEEPSAFE DELUXE KMI J. T. POSEY COMPANY 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SQUARE CHAIR SENSOR PAD 8308, LOT # UNK