BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6115220 · Received November 18, 2016

    Report

    Report Number
    2031702-2016-01465
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    August 27, 2016
    Report Date
    November 18, 2016
    Manufacturer
    CAREFUSION, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER DATE OF EVENT REPORTED, THE DEVICE WAS RETURNED TO CAREFUSION FOR A 6YR TURBINELESS PREVENTATIVE MAINTENANCE (PM) AND WAS RECEIVED ON 21SEP2016. AT THAT TIME, THERE WAS NO REPORTED ISSUE, EVENT, NOR ALLEGATION OF MALFUNCTION AGAINST THE VENTILATOR; THE CUSTOMER REQUESTED ONLY A PM SERVICE. AFTER THE DEVICE HAD ALREADY BEEN RETURNED TO THE CUSTOMER, THE MEDWATCH FROM THE FDA WAS RECEIVED AND CAREFUSION BECAME AWARE OF THE EVENT. THE DEVICE CAN NOT BE RETURNED FOR FURTHER INVESTIGATION DUE TO IT ALREADY BEING RETURNED AND PM SERVICE BEING PERFORMED ON IT. PM SERVICE RECORD WAS REVIEWED AND THERE WERE NO FAILURES DETECTED, THE DEVICE PASSED ALL TESTING. NO FURTHER INVESTIGATION IS ANTICIPATED.

    Description of Event or Problem · 1

    PER RECEIVED FDA MEDWATCH, THE FOLLOWING ARE TWO DESCRIPTIONS OF THE EVENT: 1ST DESCRIPTION: "THIS WRITER HEARD PATIENT VENT ALARMING, SO ARRIVED WITHIN 30 SECONDS TO FIND RN WITH PATIENT WHO WAS C/O SOB. UPON ARRIVAL, I NOTICED THAT THE VENT WAS NOT DELIVERING BREATHS SO I ASKED RN TO USE AMBU BAG TO VENTILATE THE PATIENT WHO WAS STILL ALERT AND RESPONSIVE. AFTER 1-1.5 MINUTES, THE PATIENT HAD DECREASED MENTAL STATUS AND PROGRESSED TO UNRESPONSIVE AT WHICH POINT A RAPID RESPONSE WAS CALLED. PULSE OXIMETRY (POX) THROUGHOUT THE EVENT WAS 99-100%. LTV VENT CHANGED OUT. THE PATIENT RETURNED TO BASELINE MENTAL STATUS, BUT LETHARGIC BEFORE RR TEAM HAD ARRIVED." 2ND DESCRIPTION: "PER MY RAPID RESPONSE NOTE, PATIENT VENT STOPPED DELIVERING BREATHS AND DID ALARM STAFF TO SITUATION. UPON ARRIVAL WITHIN 30 SECONDS OF ALARM, FOUND RN WITH PATIENT WHO COMPLAINED ABOUT NEEDING TRACH ADJUSTED PER SOB. AS VENT FOUND NOT TO BE VENTILATING THE PATIENT, THIS WRITER ASKED RN TO USE AMBU BAG TO VENTILATE. POX ALWAYS AT 99-100%. THE PATIENT WAS ALERT AT THE ONSET OF AMBU BAGGING, BUT AFTER 1-1.5 MINUTES HAD DECREASED MENTAL STATUS (MS) AND PROGRESSED TO UNRESPONSIVE. PATIENT PLACED ON ANOTHER LTV."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764170 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1 35 Required Intervention