BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3023120 · Received February 27, 2013

    Report

    Report Number
    2518422-2013-00316
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    RESPIRONICS INC
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL AND THE CUSTOMER'S COMPLAINT WAS CONFIRMED. THE POWER CORD WAS PHYSICALLY DAMAGED (APPEARED TO HAVE BEEN CUT) AND HAD EVIDENCE OF A THERMAL EVENT. NO ELECTRICAL WIRES WERE EXPOSED THAT WOULD PRESENT A SHOCK HAZARD. THE DEVICE'S POWER CORD WAS REPLACED TO ADDRESS THE ISSUE. THE DEVICE HAD NO EVIDENCE OF THERMAL DAMAGE TO THE ENCLOSURE. THE DEVICE OPERATED AS DESIGNED.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A VENTILATOR'S POWER CORD WAS BURNED. THE DEVICE WAS NOT IN PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84702 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1