BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP

    MDR report key: 7774397 · Received August 10, 2018

    Report

    Report Number
    3018859-2018-00141
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 3, 2018
    Report Date
    July 12, 2018
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (02/26/2019) NATUS FACTORY SERVICE TESTED THE ACTUAL SUSPECTED DEVICE WITH SN# (B)(4) PER NATUS DOC-001692 REV.O AND PASSED. LOANER TSM SN# (B)(4) WAS ALSO TESTED PER FT-401352 REV.H AND PASSED. NATUS WAS UNABLE TO CONFIRM CUSTOMER COMPLAINT OF "WATER LEAK ERROR" AND THE UNIT WERE RETURNED TO LOANER POOL.

    Additional Manufacturer Narrative · 1

    RETURN OF THE COOL-CAP SYSTEM HAS BEEN REQUESTED BY NATUS TECHNICAL SERVICE, BUT THE SYSTEM HAS NOT BEEN RETURNED. AN INVESTIGATION IS IN PROGRESS AND A CAUSE HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NATUS THAT AFTER PAUSING A PATIENT'S COOL-CAP TREATMENT TO TAKE AN ULTRASOUND, AN A51 WATER LEAK ERROR WAS EXPERIENCED WHEN ATTEMPTING TO RESUME TREATMENT. IT WAS NOT SPECIFIED BY THE COMPLAINANT WHERE THE WATER LEAKED FROM. IN ORDER TO TROUBLESHOOT THE ISSUE, THE WATER CAP WAS CHANGED AND THE SYSTEM WAS RESTARTED. UPON RESTARTING THE SYSTEM, THE ERROR MESSAGE CLEARED AND TREATMENT RESUMED. THE TROUBLESHOOTING PROCESS DELAYED THERAPY BY ABOUT ONE HOUR. AFTER TREATMENT WAS COMPLETED, THE SYSTEM WAS NO LONGER USED ON ACCOUNT OF THE ISSUE THAT HAD OCCURRED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615146 OLYMPIC COOL-CAP COOL-CAP MXM NATUS MEDICAL INCORPORATED 401701-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other