BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL-CAP

    MDR report key: 7179627 · Received January 10, 2018

    Report

    Report Number
    3018859-2018-00030
    Event Type
    Malfunction
    Date Received
    January 10, 2018
    Report Date
    December 13, 2017
    Manufacturer
    NATUS MEDICAL INC.
    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

    THE SUSPECTED COOL-CAP UNIT SN#(B)(6) WAS RETURNED BACK TO NATUS ON (B)(6) 2018 FOR REPAIR, NATUS FACTORY SERVICE DID THE REPAIR AND NOTED "UNABLE TO CONFIRM COMPLAINT OF "MAJOR WATER LEAK" ERROR.UNIT PASSED COOL CAP FULL FTP DOC-001692 N". ON (B)(6) 2018) THE UNIT WAS SENT TO CUSTOMER AND NATUS TECHNICAL SERVICE MADE FOLLOW UP ATTEMPTS ON (B)(6) 2018 & (B)(6) 2018) TO GET AN UPDATE ON THE UNIT, NO RESPONSE WAS RECEIVED FROM CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS PLACED INTO A BACKUP COOLING DEVICE. THE CUSTOMER HAS NOT REPORTED THE ALARM IDENTIFIER, THE PATIENT'S RECTAL TEMPERATURE OR THE SPECIFIC HOURS OF TREATMENT. FOLLOW UP COMMUNICATION ATTEMPTS WITH THE CUSTOMER WERE CARRIED OUT ON 14 DEC 2017 AND 09 JAN 2018. THESE FOLLOW UP ATTEMPTS HAVE BEEN UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION THUS FAR. THE CUSTOMER HAS SINCE PLACED AN ORDER FOR DEVICE SERVICE AND A LOANER COOL CAP UNIT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED NATUS TECHNICAL SERVICE TO REPORT THAT, PRIOR TO THE CALL, THE COOL CAP DEVICE WAS INDICATING THAT THERE WAS A MAJOR WATER LEAK AND THE PATIENT HAD BEEN COOLING FOR TWO DAYS. THE CUSTOMER CONFIRMED THAT THERE WAS NO APPARENT WATER LEAKAGE, BUT THE MAIN HOSE (RED) WAS REPORTED NOT TO BE COMPLETELY CONNECTED. THE CUSTOMER ALSO REPORTED A FULL WATER BAG. AFTER PROPERLY CONNECTING THE MAIN HOSE, THE ISSUE STILL PERSISTED, AND THE CUSTOMER WAS UNABLE TO CLEAR THE ERROR. THE COOL CAP WAS REBOOTED, AND DURING THE REBOOT PROCESS, THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT FILL AND THAT THE RESUME SELECTION WAS "GRAYED OUT." THE CUSTOMER ATTEMPTED TO REPLACE/SPIKE A NEW BAG. THE CUSTOMER ALSO REPORTED THAT THE AREA WAS LOUD, WHICH WOULD NOT ALLOW THEM TO VERIFY IF THE PUMP WAS ACTIVE OR IF THE SYSTEM MADE ANY CLICKING NOISES. NO DEATH, SERIOUS INJURY, DELAY IN CARE OR ENVIRONMENTAL/SAFETY CONCERNS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21334 OLYMPIC COOL-CAP COOL-CAP MXM NATUS MEDICAL INC. 401352-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other