BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 3150147 · Received May 1, 2013

    Report

    Report Number
    2021710-2013-00028
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FOLLOWING INFORMATION CONCERNING THE EVAL OF THE DEVICE BY THE USER FACILITY WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REP. THE USER FACILITY REP EVALUATED THE DEVICE AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS A FAULTY 3-OHM DRIVER AND DRIVER POWER MODULE. AS A CORRECTION, CAREFUSION SENT A REPLACEMENT 3-OHM DRIVER AND DRIVER POWER MODULE TO THE USER FACILITY TO REPAIR AND RETURN THE DEVICE BACK TO SERVICE. THE ALLEGED FAULTY DEVICES WERE RECEIVED BY CAREFUSION, ROUTED TO CAREFUSION FAILURE ANALYSIS LAB AND STAGED FOR EVAL. ONCE THE EVAL IS COMPLETE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH USER FACILITY REP(S) ON (B)(4) 2013. "[NAME REMOVED] CALLED TO REPORT THAT THIS VENTILATOR WAS INVOLVED IN AN INCIDENT LAST NIGHT. HE EXPLAINS THAT THE DRIVER SUDDENLY STOPPED WHILE ON A PT. THEY TRIED TO RESTART THE VENTILATOR, BUT THEY WERE UNABLE DESPITE THE SYSTEM BEING PRESSURIZED. THE ALARMS SOUNDED APPROPRIATELY SO THE PT WAS QUICKLY PLACED ON ANOTHER VENTILATOR. NO PT COMPROMISE. [NAME REMOVED] IS FACTORY TRAINED SO HE EVALUATED THE UNIT. HE FOUND THAT WHEN HE MEASURED P20 (DRIVER), HE MEASURED VALUE WAS UNSTABLE. HE COULD NOT MEASURE 3 OHMS. HE THEN EVALUATED THE PWM LIGHT. THIS LIGHT REMAINED RED DESPITE BEING PRESSURIZED WITH THE START/STOP BUTTON DEPRESSED. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IS WAS SUPPOSED TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190315 CAREFUSION VENTILATOR, HIGH FREQUENCY/LSZ LSZ CAREFUSION 3100A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA ASKU