BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPAQ ENCORE

    MDR report key: 3222189 · Received June 28, 2013

    Report

    Report Number
    3222189
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    March 2, 2013
    Report Date
    June 26, 2013
    Manufacturer
    WELCH ALLYN PROTOCOL, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS IN AN EMPTY PATIENT ROOM CHARGING. THE PEDS ER STAFF NOTED A FOUL ODOR IN ROOM C. MAINTENANCE WAS CONTACTED AND IT WAS FOUND TO BE THE PROPAQ VITAL SIGNS MONITOR. THE DEVICE HAD A HOLE MELTED/BURNED INTO THE TOP WHILE CHARGING IN THE ROOM. THE HOLE IS ON THE TOP REAR OF THE DEVICE, ABOVE THE POWER SUPPLY. NO HARM TO PATIENT OR STAFF. NO VISIBLE SIGNS OF FIRE (E.G.: SMOKE OR FLAMES), ONLY AN ODOR.DUE TO THE AGE OF THE UNIT, AND BEING OUTSIDE OF WARRANTY SUPPORT, WE DO NOT INTEND TO RETURN TO THE MANUFACTURER FOR REPAIR. THE DEVICE IS UNABLE TO POWER-UP FOR BIOMED INSPECTION/DEVICE DOWNLOAD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NOT APPLICABLE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295299 PROPAQ ENCORE MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) DRT WELCH ALLYN PROTOCOL, INC. 202 EL *

    Patients

    Seq Age Sex Outcome Treatment
    1 * AN EMPTY PATIENT ROOM CHARGING.| NOT APPLICABLE TO THIS EVENT - THE DEVICE WAS IN