BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5426484 · Received February 10, 2016

    Report

    Report Number
    2021710-2016-03060
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    November 1, 2013
    Report Date
    November 1, 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 NOTED: THE REPORT COMPLAINT CONDITION WAS DUPLICATED. REPLACED THE PRESSURE TRANSDUCER AND THE ISSUE RESOLVED. RAN PERFORMANCE TEST AND THE UNIT OPERATED TO MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE AMPLITUDE KEEPS FLUCTUATING. EVERYTHING ELSE IS STEADY. CAREFUSION TECHNICAL SUPPORT SPECIALIST ADVISED THE CUSTOMER TO TAP AGAINST THE PANEL METER. SHE STATED THAT IT "JUMPED". SUPPORT SPECIALIST EXPLAINED HOW AT TIMES THE WIRES GET LOOSE AND SUGGESTED TO TAKE THIS VENT DOWN TO THEIR BIOMED. NO ADDITIONAL DETAILS RECEIVED. PATIENT INVOLVEMENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86664 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1