BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5415664 · Received February 7, 2016

    Report

    Report Number
    2021710-2016-02977
    Event Type
    Malfunction
    Date Received
    February 7, 2016
    Date of Event
    September 9, 2013
    Report Date
    September 9, 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). MFG DATE: DATE IS NOT AVAILABLE. THE PART/MODEL#- 768901-RNT SERIAL #- (B)(4) WAS RECEIVED BY CAREFUSION FACTORY SERVICE; FOUND UNIT MISSING PEDESTAL LEG AND CASTER, WATER TRAPS DAMAGED WHICH REQUIRED REPLACEMENT. ALSO NOTED FOUND DRIVER COVER WITH HOLE THROUGH IT, MAIN CHASSIS DAMAGED. REPLACED EFFECTED COMPONENTS. THE REPORTED CONDITION WAS VERIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, VENT SUFFERED EXTENSIVE DAMAGE FROM FALLING DOWN (ONTO BACK). BOTH WATERTRAPS ARE BROKEN. HE NOTICED THAT ONE OF THE CASTER WHEELS WAS BROKEN (BENT). CUSTOMER DETAILED NEEDING THE REPLACEMENT VENT URGENTLY BECAUSE THE ONE THEY RECEIVED HAS TO BE REPLACED. HE EXPLAINED THAT THEY RECEIVED THE RENTAL VENT AND CALIBRATED IT. EVERYTHING PASSED AND THEY WERE TRANSFERRING IT TO THE NICU. AS THE VENT WAS ROLLING DOWN THE HALLWAY, ONE OF THE "CASTER WHEELS BECAME LOOSE CAUSING THE VENT TO FALL DOWN". HE REPORTS THAT BOTH THE WATERTRAPS WERE DAMAGED. HE STATES THAT BECAUSE OF THIS INCIDENT, THERE IS A DELAY IN TREATMENT FOR THIS PATIENT THAT REALLY NEEDS THE 3100A. PATIENT STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73532 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1