BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE 202/EL

    MDR report key: 2022184 · Received March 11, 2011

    Report

    Report Number
    3023750-2011-00019
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    PMA / PMN Number
    K012451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION HAS BEGUN. ADDITIONAL TIME IS REQUIRED TO COMPLETE THE ANALYSIS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WELCH ALLYN WAS MADE AWARE OF AN EVENT IN WHICH A NURSE INDICATED THAT SHE WAS TRANSFERRING A PT WHICH WAS HAVING HEART RATE PROBLEMS. DURING THE EVENT, THE NURSE FOUND THAT THE PROPAQ ENCORE MONITOR SCREEN WAS PROVIDING VISUAL ALARMS BUT THE AUDIBLE ALARM OUTPUT WAS DELAYED. WELCH ALLYN FACTORY SERVICE RECEIVED THE MONITOR FOR EVALUATION AND COULD NOT CONFIRM OR DUPLICATE THE CUSTOMER ALLEGATION, HOWEVER, WELCH ALLYN FACTORY SERVICE CONFIRMED THAT WHEN HE TURNED ON THE MONITOR, NO SOUND OUTPUT WAS DETECTED. THERE WAS NO REPORT OF ANY PT HARM AS A RESULT OF THE REPORTED EVENT. NOTE 1 FOR BLOCK A: THE CUSTOMER DID NOT PROVIDE ANY PT INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE 202/EL DRT WELCH ALLYN PROTOCOL, INC. PROPAQ ENCORE 202

    Patients

    Seq Age Sex Outcome Treatment
    1