BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-102

    MDR report key: 4102401 · Received August 27, 2014

    Report

    Report Number
    2518422-2014-01476
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    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 EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, THE DEVICE STALLED. THE DEVICE'S BALLSCREW WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519022 PLV-102 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 37001

    Patients

    Seq Age Sex Outcome Treatment
    1