BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-102

    MDR report key: 3201547 · Received June 26, 2013

    Report

    Report Number
    2518422-2013-01288
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 4, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VENTILATOR WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE DEVICE'S CHECK LEAF VALVE WOULD NEED TO BE REPLACED TO ADDRESS THE ISSUE. CONCLUSION - DEVICE HAS BEEN EVALUATED BUT THE COMPONENTS WERE NOT REPLACED. IT WAS NOT FEASIBLE TO REPAIR THE DEVICE, THE DEVICE WAS SCRAPPED.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING AN ISSUE WITH A VENTILATOR'S PRESSURE DELIVERY. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290515 PLV-102 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 37006

    Patients

    Seq Age Sex Outcome Treatment
    1