BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5418238 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-03018
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    October 15, 2013
    Report Date
    October 15, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). PN: (B)(4), LOT # Y09S0369. THE DEVICE/COMPONENTS WERE NOT RETURNED FOR POSSIBLE FAILURE ANALYSIS EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CIRCUIT WILL NOT CALIBRATE UP TO 39-43, 0NLY TO 29CM. THEY HAVE TRIED 2 COMPLETE CIRCUITS. USING A SET OF CAP/DIAPHRAGMS FROM A DIFFERENT LOT# FIX THE ISSUE, THE UNIT IS AT 41CM. THE CUSTOMER ADDITIONALLY REPORTED, THEY HAD ISSUES EARLIER IN THE YEAR WITH THE CIRCUIT CALIBRATION NOT PASSING AND IT TURNED OUT IT WAS NOT THE VENT AND MOST LIKELY THE CAP/DIAPHRAGMS AT THAT TIME. THE CAREFUSION TECH SUPPORT SPECIALIST IN CONJUNCTION WITH THE CUSTOMER DETERMINED THAT THE ROOT CAUSE OF THE REPORTED EVENT WAS FAULTY CAP/DIAPHRAGMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75682 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1