BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE ESSENTIAL

    MDR report key: 3190201 · Received June 10, 2013

    Report

    Report Number
    2020362-2013-00257
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    April 16, 2013
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION DID NOT CONFIRM THE REPORTED ISSUE THAT THERE IS NO POWER. EVALUATION REVEALED THAT THE UNIT POWERS UP AS IT SHOULD. HOWEVER, WHEN THE VOICE AND TONE WERE INITIALLY TESTED THEY PLAYED ONCE, BUT WHEN RETESTED THERE WAS NO TONE SOUND AFTER THE VOICE PLAYED. NO PHYSICAL DAMAGES WERE FOUND ON THE UNIT. NOTE: INSTRUCTIONS FOR USE STATES: AFTER CHANGING BATTERIES, TEST THE ALARM FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. IF THE ALARM DOES NOT FUNCTION PROPERLY, REMOVE THE ALARM FROM SERVICE AND REPLACE IT WITH A PROPERLY FUNCTIONING ALARM. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE UNIT WILL NOT POWER ON. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. CUSTOMER REPORTED NO VISIBLE DAMAGE TO THE ALARM. CUSTOMER DID NOT KNOW WHEN THE ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262155 POSEY KEEPSAFE ESSENTIAL KMI J. T. POSEY CO. 8373 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK