BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP SYSTEM

    MDR report key: 1740301 · Received June 24, 2010

    Report

    Report Number
    3018859-2010-00003
    Event Type
    Malfunction
    Date Received
    June 24, 2010
    Date of Event
    May 29, 2010
    Report Date
    June 24, 2010
    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 IN THE PROCESS OF BEING RETURNED FROM THE CUSTOMER IN ORDER TO UNDERGO TESTING. (B)(6) WILL SUBMIT A FOLLOW-UP REPORT TO FDA WHENEVER THE DEVICE INVESTIGATION / TESTING IS COMPLETED.

    Description of Event or Problem · 1

    DURING TREATMENT OF A 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 24 HOURS INTO THE 76-HOUR TREATMENT. SYSTEM WAS FROZEN FOR 1/2 HOUR OR LESS BEFORE IT WAS DISCOVERED. RECTAL TEMPERATURE WAS 34.4C WHEN THE SCREEN FROZE. DEVICE WAS REBOOTED AND TREATMENT CONTINUED. PRIOR TO COMPLETING THE TREATMENT, THE DEVICE EXHIBITED A SECOND FROZEN SCREEN. THE DEVICE WAS AGAIN REBOOTED AND USED UNTIL A SECOND (BACKUP) DEVICE COULD BE PLACED INTO SERVICE. 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