BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 1935702 · Received December 16, 2010

    Report

    Report Number
    2020362-2010-00397
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Report Date
    October 13, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: RESULTS - EVAL FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED THE ALARM POWERED ON. THE TONE SELECTOR FEATURE DOES NOT WORK. THERE IS AN ALARM TONE WHEN PRESSURE IS OFF THE SENSOR PAD. THE UNIT BATTERY DOOR IS MISSING. THE 9V BATTERY SNAP HARD COVER IS DAMAGED. THE BLACK BATTERY WIRE HAS BEEN SOLDERED TOGETHER AND THE COPPER IS EXPOSED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS NO POWER. CUSTOMER TESTED THE UNIT WITH NEW BATTERIES. CUSTOMER DETECTS SOME DAMAGE TO THE BATTERY WIRES. THE BATTERY DOOR WILL NOT BE RETURNED. THE PRODUCT PROBLEM WAS DISCOVERED DURING USE. THERE WAS NO PT INCIDENT OR INJURY REPORTED. EVAL SHOWS WHEN TESTED THE ALARM DOES POWER UP. THE BATTER SNAP HARD COVER IS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI SQUARE CHAIR SENSOR PAD: MODEL# 8308, LOT# UNK