BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP SYSTEM

    MDR report key: 1621121 · Received February 5, 2010

    Report

    Report Number
    3018859-2010-00002
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    January 14, 2010
    Report Date
    February 5, 2010
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COOL-CAP SYSTEM RETURNED FROM CUSTOMER IS UNDERGOING TESTING IN (B)(4). NATUS MEDICAL INC WILL SUBMIT A F/U REPORT TO FDA, WHENEVER, THE DEVICE INVESTIGATION / TESTING IS COMPLETED.

    Description of Event or Problem · 1

    OLYMPIC COOL-CAP SYSTEM EXHIBITED AN UNALARMED SHUTDOWN CHARACTERIZED BY A FROZEN DISPLAY SCREEN. DEVICE EXPERIENCED THIS MALFUNCTION AT +48 HOURS INTO THE 76- HOUR TREATMENT. SYSTEM WAS FROZEN FOR ABOUT 1 HOUR BEFORE IT WAS DISCOVERED. RECTAL TEMPERATURE WAS AT 36.8C AT THAT TIME. DEVICE WAS REBOOTED AND THE REMAINDER OF THE TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC COOL-CAP SYSTEM COOLING CAP (INFANTS) MXM NATUS MEDICAL INC. 60010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1