BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3921471 · Received May 20, 2014

    Report

    Report Number
    2020362-2014-00196
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    March 10, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: RESULTS - EVALUATION OF THE RETURNED UNIT FOUND THAT THE UNIT DOES NOT SOUND CONTINUOUSLY WHEN IN USE WITH 8308 CUSTOMER'S SENSOR PAD. INSTEAD IT SOUNDS ON AND OFF WHEN THE SENSOR RECEPTACLE BEING BENT DOWN AND CORRODED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM SOUNDS CONTINUOUSLY WHEN IN USE WITH THE SENSOR. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. CUSTOMER ALSO REPORTED THERE IS NO PHYSICAL DAMAGE TO THE OUTSIDE OF THE ALARM AND DID NOT PROVIDE A DATE WHEN THE ISSUE WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299257 KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SQUARE CHAIR SENSOR PAD LOT#3288D14