BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLV-100

    MDR report key: 3202258 · Received June 28, 2013

    Report

    Report Number
    2518422-2013-01348
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    February 11, 2011
    Report Date
    February 11, 2011
    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 SVC CTR, A FAILURE RELATED TO POWER BOARD WAS OBSERVED. THE DEVICE'S POWER BOARD WAS REPLACED TO ADDRESS THE ISSUE. 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 MFR'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 MFR FOR ROUTINE PREVENTATIVE MAINTENANCE. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296167 PLV-100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 35001

    Patients

    Seq Age Sex Outcome Treatment
    1