BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2974757 · Received January 18, 2013

    Report

    Report Number
    2020362-2013-00019
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    December 19, 2012
    Manufacturer
    J. T. POSEY CO.
    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

    RESULT - EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; THE ALARM DID NOT POWER UP WHEN USING NEW BATTERIES OR AN EXTERNAL POWER SUPPLY WHEN TESTED THREE DIFFERENT TIMES. THE ALARM DID POWER ON WHEN USING THE 9V ADAPTER BUT THE ALARM DID NOT SOUND AT ALL DURING ANY FUNCTIONAL TESTS. THE ALARM WAS MISSING THE BATTERY DOOR. NOTE: THE INSTRUCTIONS FOR USE ON MAINTAINING AND STORAGE OF THE ALARM STATES: STORE THE ALARM IN A SECURE PLACE SO IT WILL NOT BE DROPPED OR DAMAGED. DO NOT USE IF; BATTERY DOOR IS MISSING; BATTERY DOOR IS DAMAGED; ALARM CASE IS DAMAGED; OR ALARM CASE IS CRACKED. DO NOT USE THE POSEY KEEPSAFE DELUXE IF THE AUDIBLE ALARM DOES NOT SOUND. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT WILL NOT POWER ON AFTER THEY REPLACED THE BATTERIES WITH NEW ONES. THERE ARE NO SIGNS OF BATTERY LEAKAGE OR CORROSION ON THE BATTERY SPRINGS AND THE BATTERY SPRINGS ARE NOT BENT. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28788 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8361 NA

    Patients

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