BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5414530 · Received February 6, 2016

    Report

    Report Number
    2021710-2016-02854
    Event Type
    Malfunction
    Date Received
    February 6, 2016
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAREFUSION FSE WENT ONSITE AND PERFORMED AN OVERHAUL, PM, AND OVP ACCORDING TO MANUFACTURER SPECIFICATIONS. UPON REMOVING THE COVER PANELS, HE FOUND DRIVER CONNECTIONS ALREADY DISCONNECTED AND THE CONTROL LUER LOCK WAS LOOSE. DURING THE FINAL CHECKOUT TESTS HE FOUND THAT THE ONE-WAY VALVES ON THE AIRSOURCE SIDE OF THE BLENDER WAS RESTRICTED BY THE ONEWAY VALVE AND POSSIBLY A POINT OF OCCLUSION. HE THEN REPLACED THE DRIVER AND PR8 REGULATOR. ADJUSTED THE POWER SUPPLY, DDI BOARD, AND DRIVER CONTROLLER. ALL VOLTAGES AND READINGS WITHIN SPECIFICATION. CALIBRATED THE AIRWAY PRESSURE XDCR AND ADJUSTED/CHECKED PNEUMATICS. TESTED THE ALARMS AND LEDS AND COMPLETED THE CHECKOUT VERIFICATION. ALL PRESSURES AND ALARMS ARE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN A RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE ON (B)(6) 2014. THE CUSTOMER CALLED TO REPORT THAT THIS UNIT IS OVERHEATING. THE CUSTOMER WAS ABLE TO SEE IT OVERHEAT IN HIS SHOP AND STATED THAT IT OVERHEATED ON A PATIENT. THEY SWAPPED THE UNIT OUT AND THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72877 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1