BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5428096 · Received February 10, 2016

    Report

    Report Number
    2021710-2016-03121
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    January 8, 2014
    Report Date
    January 8, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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) PART/LOT ARE UNKNOWN. THE DEVICE/COMPONENTS WERE NOT RETURNED FOR POSSIBLE FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT GENERATED NO PRESSURE AND THE ISSUE IS INTERMITTENT; THINKS THE DUMP SOLENOID GOING BAD. CAREFUSION TECHNICAL SUPPORT SPECIALIST SUGGESTED REPLACING THE DUMP SOLENOID SINCE IT DOES SOUND LIKE IT IS NOT ACTIVATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85128 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1