BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP SYSTEM

    MDR report key: 2209848 · Received August 2, 2011

    Report

    Report Number
    3018859-2011-00003
    Event Type
    Malfunction
    Date Received
    August 2, 2011
    Date of Event
    July 7, 2011
    Report Date
    August 2, 2011
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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.

    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. SYSTEM WAS FROZEN FOR ONE HOUR AND 44 MINUTES BEFORE IT WAS DISCOVERED. RECTAL TEMPERATURE WAS 36.9 CENTIGRADE WHEN ISSUE WAS DISCOVERED. PT WAS MOVED TO A SECOND COOL-CAP DEVICE. THE REMAINDER OF THE 3-DAY TREATMENT WAS COMPLETED WITHOUT FURTHER INCIDENT. THERE WAS NO PT INJURY. DURING INITIAL ON-SITE DEVICE TESTING, THE HOSP'S BIOMEDICAL TECH OBSERVED A FEW GREEN LINES AT THE BOTTOM OF THE SCREEN AND THE DEVICE REPEATEDLY REBOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OLYMPIC COOL-CAP SYSTEM COOLING CAP (INFANTS) MXM NATUS MEDICAL INCORPORATED 60010 NOT APPLICABLE

    Patients

    Seq Age Sex Outcome Treatment
    1