BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRITICOOL

    MDR report key: 9715165 · Received February 15, 2020

    Report

    Report Number
    1219702-2020-00016
    Event Type
    Malfunction
    Date Received
    February 15, 2020
    Date of Event
    January 11, 2020
    Report Date
    February 15, 2020
    Manufacturer
    BELMONT MEDICAL TECHNOLOGIES
    Product Code
    DWJ
    PMA / PMN Number
    K083662
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIVING THE INITIAL REPORT, WE CONTACTED THE USER FACILITY TO REQUEST THAT THE IMPLICATED WRAPS BE RETURNED TO BELMONT FOR INVESTIGATION, AND TO REQUEST THAT PHOTOGRAPHS BE PROVIDED. AS OF THE DATE OF THIS REPORT, THE WRAPS HAVE NOT BEEN RETURNED FOR EVALUATION, NOR HAVE PHOTOGRAPHS BEEN PROVIDED. THE OPERATOR'S MANUAL INFORMS THE USER: "IF MOISTURE OR LEAKS ARE DISCOVERED IN THE CONNECTING HOSE AND/OR WRAP, TURN OFF THE CRITICOOL DEVICE, DISCONNECT THE POWER CABLE FROM ITS POWER SOURCE, AND CORRECT THE PROBLEM BEFORE PROCEEDING." THE MANUAL ALSO PROVIDES A TROUBLESHOOTING GUIDE FOR WATER LEAKS, AS WELL AS THE FOLLOWING WARNING STATEMENT: "WATER MAY DRIP FROM THE INLET TUBES OF THE WRAPS. BE SURE THAT NO ELECTRICAL DEVICE OR OUTLET IS LOCATED UNDER THE CRITICOOL'S WATER INLET OR WRAP TUBES. WHEN DISCONNECTING WRAPS FROM THE CRITICOOL CONFIRM THAT THE CLAMPS ARE TIGHT, TO PREVENT WATER LEAKING FROM THE WRAP." IT WAS REPORTED THAT THE CONNECTION WAS WRAPPED AND THE LEAKING SUBSEQUENTLY STOPPED; THERE WAS NO INJURY TO THE PATIENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. WE WILL CONTINUE TO MONITOR SIMILAR REPORTS OF THIS NATURE FOR ANY TRENDS AND TAKE FURTHER ACTION IF NECESSARY.

    Description of Event or Problem · 1

    BELMONT'S SALES REPRESENTATIVE RECEIVED A COMPLAINT FROM THE USER FACILITY AND RELAYED THE FOLLOWING REPORT: "THIS PAST WEEKEND WE HAD AN ISSUE WITH WRAPS LEAKING AT THE WATER HOSE CONNECTION SITE. THE FIRST WRAP WAS 0-4KG AND WAS CHANGED AFTER THE BED WAS NOTICED TO BE SOAKED. THE SECOND 0-4KG WRAP WAS IMMEDIATELY NOTICED TO BE LEAKING AT THE CONNECTION. THEY CHANGED WATER CABLES AND THEN CHANGED TO A COMPLETELY NEW MACHINE. IT WAS STILL LEAKING SO THEY TRIED A >4KG WRAP. IT WAS STILL LEAKING AT THE CONNECTION BUT WE COULDN'T KEEP GOING THROUGH EXPENSIVE WRAPS SO THEY WRAPPED IT AND WAITED TO SEE IF IT WOULD QUIT LEAKING, WHICH IT DID. IT WAS A NEW ORDER OF WRAPS (LOT #M192481). THEY DIDN'T FEEL LIKE IT WAS AN ISSUE ON THE MACHINE SIDE, BUT RATHER THE WRAP. ANY TROUBLESHOOTING SUGGESTIONS? HAS ANYONE ELSE HAD THIS ISSUE?"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178321 CRITICOOL THERMAL REGULATING SYSTEM DWJ BELMONT MEDICAL TECHNOLOGIES INFANT CUREWRAP

    Patients

    Seq Age Sex Outcome Treatment
    1