BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2234181 · Received August 30, 2011

    Report

    Report Number
    2021710-2011-00062
    Event Type
    Malfunction
    Date Received
    August 30, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K062093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION HAS DISPATCHED A CAREFUSION FIELD SERVICE REP TO THE USER FACILITY'S SITE TO REPAIR THE DEVICE AND RETURN IT TO SERVICE. THIS IS A KNOWN ISSUE, THUS NO ADD'L INVESTIGATION/EVALUATION IS REQUIRED. CAREFUSION HAS ALREADY INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST TO ADDRESS THIS ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. "[NAME REMOVED] REPORTS THAT THE VENT ALARMED "EXT HI PPEAK" WHILE ON A PT. NO INJURY. VENT IS ISOLATED IN THE BIOMED SHOP AWAITING FLD SRVC TO REPAIR." THE FOLLOWING DESCRIPTION OF THE EVENT AND THE CONDITION OF THE PT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY CAREFUSION FROM THE FDA ON 08/02/2011. "PT'S VENTILATOR WAS MALFUNCTIONING AND DISPLAYING "EXT HIGH PPEAK" ALARM, WHICH INDICATES THE DEVICE HAS MEASURED A HIGH PEAK PRESSURE ABOVE A THRESHOLD VALUE FOR MORE THAN 5 SECONDS. PT WAS HAND VENTILATED WHILE THE DEVICE UNDERWENT TROUBLESHOOTING. VENTILATOR WAS UNABLE TO BE CALIBRATED PROPERLY AND WAS REPLACED. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? AIRWAY MANAGEMENT VIA VENTILATOR. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other ASKU