BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP

    MDR report key: 3287715 · Received August 9, 2013

    Report

    Report Number
    3018859-2013-00006
    Event Type
    Malfunction
    Date Received
    August 9, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 28, 2013
    Manufacturer
    NATUS MEDICAL INC
    Product Code
    MXM
    Removal / Correction Number
    Z-00447-2013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS PART OF AN ONGOING FIELD CORRECTIVE ACTION. "THE OLYMPIC COOL-CAP CONTROL MODULE HAS EXPERIENCED A FROZEN SCREEN DURING USE. WHEN THIS OCCURS THE ON-SCREEN INFO REMAINS ON DISPLAY BUT THE SYSTEM IS NO LONGER PROVIDING COOLING TREATMENT TO THE PT. THE VISIBLE CLOCK IN THE UPPER RIGHT HAND CORNER OF THE SCREEN STOPS ADVANCING." NATUS MEDICAL INCORPORATED CONTACTED THE FACILITY TO ADVISE OF THE FAILURE VIA (B)(4). THE HOSP FACILITY DID NOT RESPOND TO THE CORRECTIVE ACTION NOTICE DELIVERED TO THEM ON 12/12/2012. NATUS MEDICAL INCORPORATED ANTICIPATES THAT THERE WILL BE NO FURTHER F/U TO THIS REPORT, AS THE ISSUE IS UNDERSTOOD AND IS CURRENTLY BEING CORRECTED. IF NEW INFO BECOMES AVAILABLE THE F/U WILL BE FILED FOR THIS INCIDENT. NO OTHER INFO IS AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    FACILITY CONTACTED NATUS MEDICAL INCORPORATED TO REPORT THE COOL-CAP MALFUNCTION. THE DEVICE FAILED TO PERFORM AS DESIGNED. THE FACILITY CONTACTED NATUS MEDICAL INCORPORATED TO REPORT THAT THE COOL CAP MONITOR FROZE DURING TREATMENT OF A PT. THE PT WAS THEN MOVED THE PT TO ANOTHER COOL CAP UNIT AND RESUMED TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381266 OLYMPIC COOL-CAP COOL-CAP MXM NATUS MEDICAL INC 60010 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other