BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 1851334 · Received September 23, 2010

    Report

    Report Number
    2020362-2010-00246
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    August 25, 2010
    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)(4). NO CONTINUITY (ELECTRICAL SHORT). RESULTS - INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE UNIT HAS AN OPEN ELECTRICAL CIRCUIT IN THE NURSE CALL RECEPTACLE FUNCTION WHICH DOES NOT SEND A SIGNAL TO THE NURSE'S STATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CLAIMS THAT THE ALARM IS FUNCTIONING PROPERLY BUT WHEN IT WAS TESTED AGAINST A DIGITAL METER IT READS NO CONTINUITY (ELECTRICAL SHORT). THIS WAS DISCOVERED DURING SET UP. THERE WAS NO PT CONTACT.

    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 NA