BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2000098 · Received February 3, 2011

    Report

    Report Number
    2020362-2011-00032
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Report Date
    January 5, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS POWER BUT WHEN IT IS SET ON VOICE ONLY MODE IT DOES NOT SOUND. WHEN IT IS SET ON VOICE AND TONE MODE, IT PLAYS A TONE BUT NO VOICE IS HEARD. THE POWER SWITCH IS STUCK IN THE ON POSITION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT WHEN THE ALARM IS SET ON VOICE AND TONE AND PRESSURE IS OFF THE PAD THERE IS NO ALARM TONE. CUSTOMER CLAIMS THE ALARM LOOKS NEW AND HAS NO CRACKS ON THE CASE. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI OVER-THE-MATTRESS SENSOR PAD MODEL 8307, LOT# UNK