BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 2854289 · Received November 28, 2012

    Report

    Report Number
    2518422-2012-02367
    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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR'S INTERNAL BATTERY WAS NOT HOLDING A CHARGE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT YET BEEN EVALUATED BY THE MANUFACTURER. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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