BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP SYSTEM

    MDR report key: 2182419 · Received July 11, 2011

    Report

    Report Number
    3018859-2011-00002
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 11, 2011
    Manufacturer
    NATUS MEDICAL INC.,
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COOL-CAP SYSTEM IS BEING RETURNED TO NATUS MEDICAL INC FOR TESTING. A F/U REPORT WILL BE SUBMITTED TO THE FDA WHEN THE DEVICE INVESTIGATION / TESTING IS COMPLETED. ADDITIONAL SERIAL #: (B)(4).

    Description of Event or Problem · 1

    DURING TREATMENT OF AN INFANT, AN OLYMPIC COOL-CAP SYSTEM EXHIBITED A SHUTDOWN CHARACTERIZED BY A FROZEN DISPLAY SCREEN. NO AUDIBLE OR VISIBLE ALARMS WERE OBSERVED. DEVICE FIRST EXPERIENCED THIS EVENT AT APPROX 22 HRS INTO THE 76-HR TREATMENT. SYSTEM WAS FROZEN FOR 45 MINUTES BEFORE IT WAS DISCOVERED. RECTAL TEMP WAS 33.7C WHEN ISSUE WAS DISCOVERED (WITHIN 0.3C OF THE TARGET 34.0-35.0C RANGE). DEVICE WAS REBOOTED AND TREATMENT CONTINUED. DEVICE EXHIBITED A SECOND FROZEN SCREEN; TREATMENT CONTINUED AFTER REBOOTING THE DEVICE. AFTER EXHIBITING A THIRD FROZEN SCREEN, THE PT WAS SHIFTED TO A SECOND COOL-CAP DEVICE. THE REMAINDER OF THE 3-DAY 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