BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENT NEWPORT HT70 +

    MDR report key: 3388396 · Received October 1, 2013

    Report

    Report Number
    MW5032109
    Event Type
    Malfunction
    Date Received
    October 1, 2013
    Date of Event
    September 25, 2013
    Report Date
    September 30, 2013
    Manufacturer
    NEWPORT
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NURSE CALLED BECAUSE SHE WAS HAVING TROUBLE WITH PT'S HT70 VENT. ORIGINALLY IT WAS ALARMING "LOW VTE" AND "CHECK PROX LINE". SHE COULD NOT RESOLVE THESE ALARMS, SO SHE COMPLETED A "CIRCUIT CHECK" AND THE VENT DID NOT PASS. SHE CHANGED THE CIRCUIT AND DID ANOTHER CIRCUIT CHECK. THE VENT DID NOT PASS AGAIN AND WE COULD NOT RESOLVE THE ISSUE BY TROUBLESHOOTING OVER THE PHONE. PT WAS COMFORTABLE ON THE BACK UP VENTILATOR. WHEN THE RESPIRATORY THERAPIST WENT TO THE HOME TO DO VENT EXCHANGE, SHE COULD NOT GET VENT TO COMPLETE THE CIRCUIT CHECK. SHE THEN FOUND THAT THE MODE WAS DIFFERENT WHAT PT IS USUALLY ON. THE VENT WAS SET TO SPONTANEOUS / PRESSURE, BUT PT IS USUALLY SIMV PRESSURE. RESPIRATORY THERAPIST COULD NOT GET THE MODE TO SWITCH BACK. IT APPEARED AS THOUGH THE SCREEN WAS LOCKED. VENTILATOR WAS EXCHANGED AND BROUGHT BACK TO THE PHS. BIOMEDICAL DEPT ATTEMPTED TO GET THE MODES TO SWITCH BUT WERE NOT ABLE; SCREEN WAS STILL FROZEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495565 VENT NEWPORT HT70 + HT70 PLUS VENTILATOR CBK NEWPORT HT70

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR