BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP SYSTEM

    MDR report key: 1804336 · Received August 11, 2010

    Report

    Report Number
    3018859-2010-00004
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Date of Event
    July 16, 2010
    Report Date
    August 11, 2010
    Manufacturer
    NATUS MEDICAL INC
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COOL-CAP SYSTEM WAS RECENTLY RETURNED FROM THE CUSTOMER AND IS CURRENTLY UNDERGOING TESTING. NATUS MEDICAL INC WILL SUBMIT A F/U REPORT TO FDA WHEN THE DEVICE INVESTIGATION / TESTING IS COMPLETED.

    Description of Event or Problem · 1

    DURING TREATMENT OF AN INFANT, AN OLYMPIC COOL-CAP SYSTEM EXHIBITED TWO SHUTDOWNS CHARACTERIZED BY A FROZEN DISPLAY SCREEN. NO AUDIBLE OR VISIBLE ALARMS WERE OBSERVED. DEVICE FIRST EXPERIENCED THIS EVENT AT APPROX 68 HOURS INTO THE 76-HOUR TREATMENT. SYSTEM WAS FROZEN FOR AN HOUR BEFORE IT WAS DISCOVERED. RECTAL TEMPERATURE WAS 34.7C WHEN ISSUE WAS DISCOVERED. DEVICE WAS REBOOTED AND TREATMENT CONTINUED. PRIOR TO COMPLETING THE TREATMENT, THE DEVICE EXHIBITED A SECOND FROZEN SCREEN. THE DEVICE WAS AGAIN 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