BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5429168 · Received February 10, 2016

    Report

    Report Number
    2021710-2016-03141
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    September 28, 2013
    Report Date
    September 28, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 NOTED: INTERMITTENT PROBLEM. REPLACED PARTS AS NEEDED - ALARM BOARD ETC. PROBLEM WAS CORRECTED; REPLACED PWM DRIVER ASSEMBLY, AND REPLACED %I TIME DISPLAY METER. ALIGNED AND CALIBRATED VENTILATOR. VENT OPERATES TO SPECIFICATION. THE UNIT MEETS FACTORY SPECIFICATIONS. THE CAREFUSION FACTORY SERVICE DEPARTMENT HAS RECEIVED THE ALLEGED FAULTY DRIVER MODULE AND IT IS AWAITING EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMERS REPORTED, THIS UNIT WAS JUST REPAIRED AND THEY ARE HAVING SIMILAR ISSUES WITH THE % INSP TIME (%IT). HE SAID THAT THEY CAN'T GET THE %IT TO GO BELOW 38%, IT SEEMS DELAYED AS WELL. HE SAID THEY ARE RENTING A 3100A UNIT BECAUSE THIS UNIT IS STILL DOWN. PATIENT INVOLVEMENT IS UNKNOWN. NO FURTHER DETAILS WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85676 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1