BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 2854293 · Received November 28, 2012

    Report

    Report Number
    2518422-2012-02366
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 5, 2012
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, THE TUBING CONNECTED TO THE EXHALATION VALVE PORT WAS FOUND TO BE LOOSE CAUSING THE LOW PRESSURES. THE DEVICE'S TUBING WAS REATTACHED TO CORRECT THIS ISSUE.

    Description of Event or Problem · 1

    THE MFR REC'D INFO ALLEGING A VENTILATOR WAS NOT DELIVERING PRESSURE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLV-100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 35001

    Patients

    Seq Age Sex Outcome Treatment
    1