BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUMONETIC

    MDR report key: 597250 · Received June 17, 2004

    Report

    Report Number
    2031702-2004-00119
    Event Type
    Malfunction
    Date Received
    June 17, 2004
    Date of Event
    May 11, 2004
    Report Date
    June 17, 2004
    Manufacturer
    PULMONETIC SYSTEMS, INC.
    Product Code
    CBK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RRT STATED THE DEVICE SHUTDOWN AFTER A SERIES OF HW FLT AND POWER LOST MESSAGES. THE PATIENT WAS BAGGED BECAUSE THEY WERE UNABLE TO POWER THE VENT BACK NO LONGER HAD CONFIDENCE IN THE VENT. EARLIER IN THE WEEK THE DEVICE WAS ALARMING FOR HW FLT, BUT STILL OPERATING NORMALLY. ADDITIONAL INFORMATION PROVIDED: COMPANY WAS AT THE DOCTORS OFFICE AND IT BEGAN TO ALARM "LOW BATT" DESPITE BEING PLUGGED INTO WALL POWER OUTLET. WHILE COMPANY WAS LOADING INTO THE VAN, THE UNIT COMPLETELY SHUT FAILED - STOPPED WORKING, CONTINUOUSLY ALARMING, ATTEMPTING TO SHUT OFF AND COME BACK ON REPEATEDLY, RUNNING THE ROM PASSED TESTS, BUT NEVER STAYING ON AND NEVER WORKING. PLUGGED INTO CIG LIGHTER WITH THE ADAPTER DID NOT RESOLVE THE PROBLEM . WHEN I PRESSED THE BUTTON TO SHUT DOWN THE VENT IT WOULD NEVER TURN OFF BUT JUST KEPT RESTARTING AND FAILING TO COME ON AND CYCLE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMONETIC VOLUME VENTILATOR CBK PULMONETIC SYSTEMS, INC. LTV 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other