BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL-CAP

    MDR report key: 6059380 · Received October 26, 2016

    Report

    Report Number
    3018859-2016-00023
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 1, 2016
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS COMPLAINT # (B)(4). DEVICE RETURN IS ANTICIPATED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS AVAILABLE. DEVICE REQUESTED FOR INVESTIGATION

    Description of Event or Problem · 1

    THIRTY ONE HOURS INTO PATIENT TREATMENT THE A51 ERROR (MAJOR WATER LEAK) PROMPTED. THERE WERE NO VISIBLE WATER LEAKS, AND THE WATER BAG DRAINED AND WATER IS IN THE CAP AND HOSES. AFTER RESTARTING THE SYSTEM, THERE WAS NO PUMP SOUND AND NO SOLENOID CLICK. THE PROCESS WOULD NOT PROCEED BEYOND THE FILL SCREEN. PATIENT WAS MOVED TO ANOTHER DEVICE IN ORDER TO CONTINUE TREATMENT. CUSTOMER REPORTS INTERRUPTION IN TREATMENT FOR 90 MINUTES. DEVICE WAS REQUESTED TO BE RETURNED TO NATUS FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708252 COOL-CAP COOL CAP MXM NATUS MEDICAL INC. 401351-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other