BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-102B

    MDR report key: 3192152 · Received June 20, 2013

    Report

    Report Number
    2518422-2013-01253
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K842876
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER'S SERVICE CENTER, AN ISSUE RELATED TO THE DEVICE'S LOGIC BOARD WAS OBSERVED. THE DEVICE WAS RETURNED TO THE CUSTOMER UN-REPAIRED PER 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

    A VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR ROUTINE PREVENTIVE 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
    280249 PLV-102B VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1003111

    Patients

    Seq Age Sex Outcome Treatment
    1