BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ CS 244

    MDR report key: 2192595 · Received July 1, 2011

    Report

    Report Number
    3023750-2011-00064
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 1, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    PMA / PMN Number
    K012451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE CLINICIAN STATED A PT WAS BEING MONITORED WITH A PROPAQ CS MONITOR. THE BIOMEDICAL ENGINEER STATED THAT THE PROPAQ HAD BEEN MONITORING THE PT AND ALARMED APPROPRIATELY PRIOR TO PT DEFIBRILLATION. THE NURSES WERE ALERTED TO THE HEART RATE ALARM. MEDICAL TREATMENT WAS RENDERED AND THE PT WAS DEFIBRILLATED. ACCORDING TO THE BIOMEDICAL ENGINEER AT THE HOSPITAL, AFTER DEFIBRILLATION THE PROPAQ CS MONITOR DISPLAYED AN ERROR MESSAGE AND SHUT DOWN. POST DEFIBRILLATION, THE CLINICIAN STATED VITAL SIGNS DATA FROM THE PROPAQ WAS LOST. THE CLINICIAN INDICATED THAT THE PT HAS NOT BEEN CONFIRMED/ADMITTED TO THE ACUITY CENTRAL MONITORING SYSTEM; THEREFORE, THE PT'S VITAL SIGNS DATA WAS LOST WHEN THE DEVICE SHUT DOWN. THE PT EXPIRED, HOWEVER, THE PROPAQ CS MONITOR AND THE ACUITY CENTRAL MONITORING SYSTEM DID NOT CAUSE OR CONTRIBUTE TO THE PT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROPAQ CS 244 DRT WELCH ALLYN PROTOCOL, INC. PROPAQ 244 CS

    Patients

    Seq Age Sex Outcome Treatment
    1