BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPIC COOL CAP

    MDR report key: 8899375 · Received August 15, 2019

    Report

    Report Number
    3018859-2019-00008
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Report Date
    May 22, 2019
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    MXM
    PMA / PMN Number
    P040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    8/22/2019 NATUS TECHNICAL SERVICE RECEIVED RESPONSE FROM CUSTOMER THAT THERE WAS NO PATIENT ON THE DEVICE WHEN THEY DISCOVERED THE DEVICE WAS NOT WORKING. THE DELAY IN TREATMENT WAS BECAUSE THE CUSTOMER HAD A CALL FROM ANOTHER BIRTH CENTER THAT WANTED TO ASK THE AVAILABILITY OF THE EQUIPMENT AND THE CUSTOMER DID NOT HAVE ANOTHER COOL CAP DEVICE ON-SITE. THE CUSTOMER REPORTED THE PATIENT AT THE OTHER BIRTH CENTER WAS REFERRED TO ANOTHER CENTER USING ANOTHER BODY COOLING SYSTEM. NATUS TECHNICAL SERVICE REQUESTED THE SUSPECTED DEVICE RETURNED TO NATUS FOR REPAIR AND CUSTOMER HAS NOT RETURNED THIS DEVICE. IF ADDITIONAL INFORMATION BECAUSE AVAILABLE NATUS MEDICAL INCORPORATED WILL FILE A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    THE REPORTED E90 FILLING ERROR DESCRIBES A MALFUNCTION. ALTHOUGH THERE HAS BEEN NO REPORT OF PATIENT/ USER DEATH OR SERIOUS INJURY, THIS MALFUNCTION HAS THE RISK OF CAUSING SERIOUS INJURY UNDER SPECIFIC CIRCUMSTANCES IF IT WERE TO OCCUR. NATUS TECHNICAL SERVICE MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN FURTHER DETAILS REGARDING PRODUCT FUNCTIONALITY AND PATIENT STATUS AT THE TIME OF THE EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE NATUS WILL FILE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON THE (B)(6) 2019, IT WAS REPORTED TO NATUS MEDICAL INCORPORATED THERE WAS AN E-90 FILLING ERROR ON THE COOL-CAP AT CUSTOMER SITE. CUSTOMER STATED THEY OPENED SIDE COVER OF THE COOLING UNIT AND CHECKED THE DEVICE, FOUND THAT SOLENOID VALVE AND PUMP WAS WORKING WELL AND THE PATIENT CAP FILLED WITH WATER WITHOUT AIR BUBBLES. CUSTOMER TRIED REFILLING THE CAP AFTER THE ERROR AND THE ISSUE STILL PERSISTED AS THE DEVICE COULD NOT RECOGNIZE THAT THE CAP WAS FILLED WITH WATER AND DIDN'T PASS THE STEP TO START THE COOLING STAGE. TECHNICAL SERVICE REPRESENTATIVE REQUESTED CUSTOMER TO PROVIDE MORE INFORMATION ON PRODUCT FUNCTIONALITY AND PATIENT STATUS AT TIME OF EVENT. TECHNICAL SERVICE REPRESENTATIVE RECOMMENDED THE CUSTOMER SEND IN THE UNIT FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692056 OLYMPIC COOL CAP COOL CAP MXM NATUS MEDICAL INCORPORATED 401701-501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other