BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ CS 246

    MDR report key: 2831398 · Received October 11, 2012

    Report

    Report Number
    3023750-2012-00079
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    PMA / PMN Number
    K012451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEIR PROPAQ CS MONITOR POWERS DOWN WHEN NIBP (NON-INVASIVE BLOOD PRESSURE MONITORING) IS INITIATED. THE UNEXPECTED SHUTDOWN OF A BEDSIDE MONITOR MAY IMPACT CLINICIAN'S ABILITY TO HEAR AND SEE CHANGES IN THE PATIENT'S CONDITION. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPAQ CS 246 DRT WELCH ALLYN PROTOCOL, INC. PROPAQ 246 CS

    Patients

    Seq Age Sex Outcome Treatment
    1