BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5415658 · Received February 7, 2016

    Report

    Report Number
    2021710-2016-02964
    Event Type
    Malfunction
    Date Received
    February 7, 2016
    Report Date
    August 22, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL REPORT WAS IDENTIFIED AS A LATE SUBMISSION DURING A TWO YEAR RETROSPECTIVE REVIEW OF COMPLAINTS AND MDR¿S FOLLOWING RECEIPT OF AN UNTITLED LETTER ISSUED BY THE FDA. (B)(4). A CAREFUSION FIELD SERVICE REPRESENTATIVE VISITED THE USER FACILITY TO EVALUATE THE DEVICE. DURING THE COURSE OF THE EVALUATION THE FIELD SERVICE REPRESENTATIVE RAN THE UNIT AND COULD NOT DUPLICATE PROBLEM. UNIT NEEDED A 12 K PM AND ALSO 7 YEAR PM. REPLACED ALL PARTS IN PM KIT. PERFORMED PREVENTATIVE MAINTENANCE (PM) SERVICE, UVT, AND OVP ACCORDING TO MANUFACTURER SPECIFICATIONS. NO PARTS WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DRIVER STOPPED TWICE ON THE PATIENT. NO OTHER INFORMATION PROVIDED. THE PATIENT WAS MOVED TO ANOTHER UNIT. THE UNIT ALARMED APPROPRIATELY. THE UNIT HAS 11,485.2 HRS AND IS A 2005 UNIT AND THE POWER MODULE IS OVERDUE. NO HISTORY THAT DETAILS THAT THE DRIVER WAS EVER REPLACED. THE UNIT IS OVERDUE FOR THE 7YR PM AND THE CAREFUSION TECHNICAL SUPPORT REP RECOMMENDED COMPLETING THE 12K PREVENTATIVE MAINTENANCE, IT IS CLOSE TO 12K HRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73529 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1