BEUDAMED
    FDA Adverse Event Summary report: N

    COOL CAP

    MDR report key: 1970889 · Received January 14, 2011

    Report

    Report Number
    1970889
    Date Received
    January 14, 2011
    Date of Event
    November 15, 2010
    Report Date
    December 14, 2010
    Manufacturer
    NATUS MEDICAL
    Product Code
    MXM
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INFANT IN REWARMING PHASE WHEN COOL CAP MACHINE MADE A "POP" NOISE. A BURNING SMELL WAS NOTED NEAR THE MACHINE AND THE SCREEN WENT BLACK. THE DEVICE WAS IMMEDIATELY UNPLUGGED FROM THE WALL OUTLET. ALL PROBES WERE REMOVED FROM THE INFANT AND AWAY FROM THE BED. INFANT WAS PLACED ON COOLING BLANKET TO CONTINUE THERAPY.====================== HEALTH PROFESSIONAL'S IMPRESSION======================SECOND INCIDENT OF SAME CIRCUMSTANCES WITHIN FOUR MONTH PERIOD. UNKNOWN CAUSE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOL CAP CAP, COOLING, INFANT MXM NATUS MEDICAL COOL CAP *

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA