BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY PERSONAL ALARM

    MDR report key: 1821296 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00180
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    June 25, 2010
    Manufacturer
    POSEY MEDICAL DEVICE LTD.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVALUATION SHOWS THAT THE UNIT POWERS ON, BUT THERE'S NO ALARM TONE WHEN THE MAGNET IS REMOVED FROM THE MAGNET PLATE. THERE WAS NO VISUAL DAMAGE TO THE ALARM UNIT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS NO POWER. THE ALARM WAS TESTED WITH NEW BATTERIES. CUSTOMER DETECTS NO VISIBLE DAMAGE TO THE UNIT, BATTERY OR CONNECTORS. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED. EVALUATION FOR THE RETURNED PRODUCT SHOWS THAT THE UNIT POWERED ON, BUT THERE'S NO ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY PERSONAL ALARM KMI POSEY MEDICAL DEVICE LTD. 8202L NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI