BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WIRELESS PERSONAL PAGER

    MDR report key: 2478474 · Received February 16, 2012

    Report

    Report Number
    2020362-2012-00071
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    January 18, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INSPECTION OF THE RETURNED PRODUCT REVEALED THE TRANSMITTER DOES NOT SIT FLUSH. THE UNIT ONLY ALARMS FROM A MAXIMUM DISTANCE OF A FOOT. BOTH THE CHIME AND VIBRATE FUNCTIONAL WORK AS THEY SHOULD. UNIT WAS TESTED WITHOUT ANY INTERFERING OBSTACLES. NOTE: POSEY INSTRUCTIONS FOR USE. CHANGE BATTERIES AT ONCE IF: TRANSMITTER LED LIGHT IS DULL OR FAILS TO ILLUMINATE; OR PAGER SIGNAL IS WEAK OR TONE IS INAUDIBLE. CHECK SIGNAL RANGE OF PAGER. A 100 FT (30 M) IS NORMAL, BUT MAY VARY DEPENDING ON BUILDING CONSTRUCTION. MAKE SURE TO STAY IN RANGE AT ALL TIMES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN YOU STAND AS FAR AS 8-10 FEET AWAY FROM THE TRANSMITTER AND PRESS THE PAGER THERE IS NO ALARM. THE BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE TRANSMITTER OR PAGER. THERE WAS NO PATIENT CONTACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRELESS PERSONAL PAGER KMI J. T. POSEY CO. 8272 801428

    Patients

    Seq Age Sex Outcome Treatment
    1 NA