BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 6201474 · Received December 22, 2016

    Report

    Report Number
    2021710-2016-05101
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 23, 2016
    Report Date
    January 26, 2017
    Manufacturer
    CAREFUSION, INC
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER INITIALLY REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. UPON FOLLOW UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION, THEY REPORTED THAT THE DEVICE WAS OPERATING ON A PATIENT AT THE TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPLACED SEVERAL COMPONENTS AND RETURNED THEM TO CAREFUSION FOR FURTHER INVESTIGATION. INVESTIGATION IS CURRENTLY PENDING. ONCE THE INVESTIGATION RESULTS ARE COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENTS, A 3100A DRIVER AND 3100A POWER CABLE ASSEMBLY, AND EVALUATED THE DEVICE. AN EVALUATION OF THE 3100A DRIVER DID NOT DUPLICATE THE REPORTED ISSUE. AN EVALUATION OF THE 3100A POWER CABLE ASSEMBLY VERIFIED THAT THE BLACK CAPACITOR ON THE POWER CORD IS BURNED. THE COMPONENT HAD BEEN BURNED AND DAMAGED, THEREFORE, THE COMPLAINT REPORTED ISSUE COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    THE VENTILATOR WAS IN USE ON A PATIENT WHEN THE REPORTED ISSUE OCCURRED. THE UNIT WAS IMMEDIATELY SWAPPED OUT AND THERE WAS NO PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BLACK CAPACITOR ON THE POWER CORD SPONTANEOUSLY CAUGHT ON FIRE WHEN PLUGGED INTO A UNIVERSAL POWER SUPPLY. THE VENTILATOR WAS NOT TURNED ON WHEN IT WAS BEING PLUGGED IN. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849342 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION, INC 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R