BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVASIVE CIRCUIT ASSEMBLY

    MDR report key: 2926426 · Received January 15, 2013

    Report

    Report Number
    2518422-2013-00092
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K982454
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVASIVE CIRCUIT ASSEMBLY WAS NOT RETURNED TO THE MFR. THE REPORTER OF THE EVENT CONFIRMED THE CUSTOMER INSERTED THE "TAIL" OF THE EXHALATION PORT CAP INTO THE EXHAUST VENT. THE DEVICE THAT WAS BEING USED IN CONJUNCTION WITH THE INVASIVE CIRCUIT ASSEMBLY ALARMED AS DESIGNED TO ALERT THE CAREGIVER OF THE EVENT. THE OCCLUSION DID NOT OCCUR DUE TO A MFG OR PACKAGING ISSUE. A REVIEW OF LABELING FOR THE INVASIVE CIRCUIT ASSEMBLY WAS PERFORMED BY THE MFR. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING, "THE EXHAUST VENT ON THE EXHALATION PORT IS DESIGNED TO EXHAUST CO2 FROM THE PT CIRCUIT. CONTINUOUS FLOW IS REQUIRED FOR SAFE OPERATION. DO NOT BLOCK OR OTHERWISE TRY TO SEAL THE EXHAUST VENT ON THE EXHALATION PORT." AND "BEFORE INSTITUTING MECHANICAL VENTILATION, CONFIRM THE PROPER CONNECTION OF THE CIRCUIT AND VERIFY VENTILATOR OPERATION. PT, VENTILATOR, AND CIRCUIT MUST BE MONITORED ON A REGULAR BASIS ACCORDING TO ESTABLISHED STANDARDS OF CARE." THE MFR CONCLUDES THE REPORTED EVENT WAS THE RESULT OF USER ERROR AND WAS NOT CAUSED BY A DEFICIENCY OF THE PRODUCT.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO OF AN INSTANCE WHERE THE CUSTOMER INSERTED THE "TAIL" OF THE EXHALATION PORT CAP INTO THE EXHAUST VENT OF THE EXHALATION PORT ON AN INVASIVE CIRCUIT ASSEMBLY. THERE WAS NO PT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22542 INVASIVE CIRCUIT ASSEMBLY VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE CBK RESPIRONICS INC. 652002

    Patients

    Seq Age Sex Outcome Treatment
    1 BIPAP VISION