BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-102

    MDR report key: 2904137 · Received January 3, 2013

    Report

    Report Number
    2518422-2013-00023
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVAL OF THE DEVICE AT THE MFR'S SVC CTR, AN ISSUE WITH THE VENTILATOR'S POWER BOARD WAS OBSERVED. THE DEVICE'S POWER BOARD WAS REPLACED TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3679 PLV-102 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 37001

    Patients

    Seq Age Sex Outcome Treatment
    1