BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP

    MDR report key: 7873604 · Received September 13, 2018

    Report

    Report Number
    3018859-2018-00150
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Report Date
    August 14, 2018
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NATUS TECHNICAL SERVICE HAS REQUESTED RETURN OF THE SYSTEM, THE UNIT WAS RECEIVED BY NATUS FOR REPAIR ON 10/23/2018. NATUS FACTORY SERVICE CONFIRMED CUSTOMER COMPLAINT AND FOUND A FAULTY COOLING MODULE ON B SIDE OF COOLING BLOCK. THUS, ONLY ONE SIDE OF THE COOLING BLOCK WAS FUNCTIONING, THIS WAS THE ROOT CAUSE OF THE ISSUE. BOTH COOLING MODULES INSIDE COOLING BLOCK WERE REPLACED AND THE PROBLEM WAS FIXED. CD DRIVE WAS ALSO FOUND TO HAVE TRAY ISSUE AND WAS REPLACED. UNIT WAS FIXED AND PASSED COOL CAP FTP DOC-001692 REV. O. THE UNIT WAS SENT TO CUSTOMER ON 11/08/2018 AND NATUS TECHNICAL SERVICE MADE FOLLOW UP WITH CUSTOMER TO CHECK THE STATUS OF THE DEVICE. CUSTOMER CONFIRMED THAT THE EQUIPMENT HAS BEEN SUCCESSFULLY INSTALLED WITH NO ISSUES.

    Additional Manufacturer Narrative · 1

    NATUS TECHNICAL SERVICE HAS REQUESTED RETURN OF THE SYSTEM. NATUS TECHNICAL SERVICE HAS SENT QUESTIONS TO THE COMPLAINANT REGARDING THE DETAILS OF THE EVENT AND THE PATIENT INVOLVED IN THE EVENT. A RESPONSE TO THESE REQUESTS HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COOL-CAP SYSTEM'S CAP TEMPERATURE WAS HIGH AS COMPARED TO THE SET TEMPERATURE. A PATIENT WAS BEING TREATED WITH THE SYSTEM WHEN THE EVENT OCCURRED, AND THE PATIENT WAS MOVED TO ANOTHER COOL-CAP SYSTEM. THERE WAS NO DEATH, SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS. A SERVICE TECHNICIAN WHO REPORTED THE EVENT PERFORMED A HEAT LOAD TEST AS DESCRIBED IN THE COOL-CAP SERVICE MANUAL AND FUNCTIONAL TEST PROCEDURE. THE TECHNICIAN CLAIMED THAT THE TEST DEMONSTRATED THAT THE INTERNAL THERMISTORS WERE FAULTY. HOWEVER, BASED ON PHOTOS PROVIDED BY THE TECHNICIAN, NATUS FACTORY SERVICE NOTED THAT THE HEAT LOAD TEST WAS PERFORMED INCORRECTLY. NATUS FACTORY SERVICE STATED THAT TESTING THE FUNCTIONALITY OF THE COOLING MODULES WOULD ALSO REQUIRE PERFORMING A DIFFERENT TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713822 OLYMPIC COOL-CAP COOL-CAP MXM NATUS MEDICAL INCORPORATED 005094

    Patients

    Seq Age Sex Outcome Treatment
    1 Other