BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GARBIN 1

    MDR report key: 3192186 · Received June 20, 2013

    Report

    Report Number
    2518422-2013-01188
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING EVAL OF THE DEVICE AT THE MFR'S SERVICE CENTER, "VENTILATOR INOPERATIVE" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S SENSOR BOARD, AND POWER MANAGEMENT BOARD WERE 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 SERVICE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281719 GARBIN 1 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1058180

    Patients

    Seq Age Sex Outcome Treatment
    1