BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 3913346 · Received May 14, 2014

    Report

    Report Number
    2518422-2014-00789
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K832467
    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 SERVICE CENTER, THE DEVICE TRIPPED THE 5 AMP BREAKER. THE DEVICE'S BALLSCREW ASSEMBLY WAS REPLACED TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    A VENTILATOR WAS RETURNED TO THE MFR FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288177 PLV-100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 35001

    Patients

    Seq Age Sex Outcome Treatment
    1