BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70

    MDR report key: 1960014 · Received December 21, 2010

    Report

    Report Number
    1960014
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 9, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE RN WAS OBTAINING A WEIGHT FOR THE NEONATE. THE PORTABLE MONITOR WAS REPORTED TO MAKE A "POPPING" NOISE AND THE SCREEN APPEARED TO HAVE INTERMITTENT LIGHT. AT THIS TIME, THE RN NOTED AN ODOR OF SMOKE ("BURNT PLASTIC SMELL") EMITTING FROM THE MONITOR AND THE SCREEN WENT BLACK. SHE IMMEDIATELY DETACHED THE MONITOR FROM THE INFANT AND UNPLUGGED THE UNIT. A REPLACEMENT MONITOR WAS SUBSEQUENTLY OBTAINED WITHOUT ISSUE.HEALTH PROFESSIONAL'S IMPRESSION: THE MONITOR MALFUNCTIONED. THE ODOR OF SMOKE WAS PRESENT FROM THE BACK OF THE MONITOR AND THE SCREEN FAILED.MANUFACTURER RESPONSE FOR MONITOR, PHYSIOLOGICAL, MP70: THE VENDOR WAS CONTACTED AT THE TIME OF THE EVENT. THE BIOMEDICAL DEPARTMENT WAS NOTIFIED IMMEDIATELY TO EVALUATE THE UNIT. THE UNIT WAS REMOVED FROM SERVICE FOR EVALUATION. THE BIOMEDICAL TECHNICIAN DISCOVERED THAT THE POWER SUPPLY BOARD WAS BURNT AND REPLACED THE BOARD. PHILIPS WAS THEN CONTACTED TO UPDATE THE SOFTWARE. THE MONITOR WAS TESTED FOR 2 DAYS TO VERIFY THE UNIT WORKED ACCORDING TO THE MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 MONITOR, PHYSIOLGICAL MHX PHILIPS MEDICAL SYSTEMS M8007A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *