BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIC-CARTRIDGE

    MDR report key: 19513 · Received February 7, 1995

    Report

    Report Number
    MW1005031
    Event Type
    Malfunction
    Date Received
    February 7, 1995
    Manufacturer
    MAUNA LOA MEDICAL, INC.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR CIRCUITS ARE NOT PASSING THE LEAK TEST WHEN RESPIRATORY THERAPISTS PERFORM THE USER VERIFICATION TEST. THE LEAK IS COMING FROM THE DUMP VALVE ON THE HUMIDIFIER BLOCK ASSEMBLY. CLINICAL ENGINEERING VERIFIED THIS BY PLACING A THUMB OVER THE VALVE AND THE LEAK STOPPED. REPORTER CONTACTED THE COMPANY LAST DECEMBER ABOUT THE LEAK FAILURE. TO PREVENT ANY FURTHER PROBLEMS, THEY SENT NEW BLOCK ASSEMBLIES AND ASKED RPTR TO SEND BACK THE UNITS NOT PASSING THE LEAK TEST. THE REPLACEMENT ASSEMBLIES ALSO LEAK AND THE COMPANY SUGGESTS RPTR KEEP REPLACING THE PT BLOCK ASSEMBLIES UNTIL THE USER VERIFICATION TEST PASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIC-CARTRIDGE NIC-CARTRIDGE BZO MAUNA LOA MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *