BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2123395 · Received June 10, 2011

    Report

    Report Number
    2020362-2011-00202
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Report Date
    March 16, 2011
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: EVAL OF THE PRODUCT FOUND THE POWER SWITCH IS DIFFICULT TO SLIDE BUT STILL FUNCTIONS. THE BATTERY DOOR IS MISSING. THERE IS VISIBLE BATTERY ACID LEAKAGE ON THE BATTERY RIBBON. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM HAS NO POWER WHEN TESTED WITH A NEW BATTERY AND A WORKING SENSOR PAD. THE CUSTOMER REPORTED THE ALARM MAY BE MISSING THE HOLD/SUSPEND BUTTON. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI