BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-102

    MDR report key: 3192135 · Received June 20, 2013

    Report

    Report Number
    2518422-2013-01248
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    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 MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. AN ISSUE RELATED TO THE DEVICE'S POWER BOARD WAS OBSERVED. THE DEVICE WAS RETURNED TO THE CUSTOMER UN-REPAIRED, AT THE CUSTOMER'S REQUEST. THIS REPORT IS BEING SUBMITTED AS PART OF A PROGRAM TO RETROSPECTIVELY REVIEW POSSIBLE DEVICE MALFUNCTIONS THAT DID NOT INVOLVE ANY INJURY, TO DETERMINE WHETHER THEY ARE REPORTABLE UNDER 21 CFR PART 803 AND THE MANUFACTURER'S UPDATED REPORTING PROCEDURES. THIS PROGRAM IS BEING UNDERTAKEN TO ADDRESS FDA WARNING LETTER 12-PHI-01.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR WOULD NOT DELIVER AIRFLOW. THE DEVICE WAS NOT IN PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280604 PLV-102 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 37006

    Patients

    Seq Age Sex Outcome Treatment
    1