BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP

    MDR report key: 1024343 · Received February 25, 2008

    Report

    Report Number
    1024343
    Event Type
    Malfunction
    Date Received
    February 25, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 25, 2008
    Manufacturer
    OLYMPIC MEDICAL CORPORATION
    Product Code
    MXM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    TERM FEMALE BABY ADMITTED TO NICU FOR PERINATAL ASPHYXIA. BABY MET CRITERIA AND PLACED ON OLYMPIC HEAD COOLING SYSTEM. APPROXIMATELY THIRTY MINUTES AFTER COOLING WAS INITIATED, THE SPECIALIST REPORTED THAT THE CAP TEMPERATURE WAS NOT RESPONDING TO SETTINGS AND THE CAP TEMPERATURE CONTINUED TO FALL DESPITE INCREASES THE CAP TEMPERATURE. CAP READING WAS CONSISTENTLY BETWEEN 5.2 AND 5.5 (MANUFACTURER RECOMMENDS CAP NO LOWER THAN 8 DEGREES). A WARMER WAS USED TO MAINTAIN APPROPRIATE RECTAL AND FONTANEL TEMPERATURES. ALSO, ORDERS WERE PLACED TO CHECK THE BABY'S SCALP EVERY FOUR HOURS (MANUFACTURER RECOMMENDS EVERY 12 HOURS) AND THE BABY WAS REPOSITIONED EVERY TWO HOURS. A TELEPHONE CALL WAS PLACED TO OLYMPIC TECHNICAL SUPPORT LINE. AFTER SEVERAL HOURS IT WAS DETERMINED THAT THERE WAS A POWER SUPPLY ISSUE THAT PROHIBITED THE MACHINE FROM RESPONDING TO THE MESSAGE FROM THE SOFTWARE TO INCREASE CAP TEMPERATURE. POSSIBLE RISKS FOR CONTINUING TO USE THE CAP WERE DISCUSSED WITH TECHNICAL SUPPORT, HOWEVER GIVEN THE BABY'S CONDITION A MEDICAL DECISION, WITH CONSENT FROM THE FAMILY, WAS MADE TO CONTINUE WITH THE THERAPY. NO OTHER COMPLICATIONS WERE NOTED DURING THE DURATION OF THE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC COOL-CAP HYPOTHERMIC DEVICE, HEAD MXM OLYMPIC MEDICAL CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA NO OTHER THERAPIES| NO OTHER THERAPIES