BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5415327 · Received February 6, 2016

    Report

    Report Number
    2021710-2016-02907
    Event Type
    Malfunction
    Date Received
    February 6, 2016
    Date of Event
    July 11, 2013
    Report Date
    July 11, 2013
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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). THE POWER ASSY ALARM WAS DOCUMENTED AS RECEIVED; AN EVALUATION IS NOT AVAILABLE AT THIS TIME, A FOLLOW-UP WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: THE CAREFUSION FAILURE ANALYSIS LAB RECEIVED THE SUSPECTED DEVICE/COMPONENT AND PERFORMED A FAILURE INVESTIGATION. THE REPORTED ISSUE WAS DUPLICATED IN THE LABORATORY SETTING. THE ROOT CAUSE OF THE REPORTED ISSUE WAS ISOLATED TO A FAULTY U12 COMPONENT ON THE ALARM BOARD ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED WHEN CHECKING OUT THIS VENT, HE FOUND IT DIFFICULT TO PERFORM THE ZERO AND SPAN. HE EVENTUALLY DID GET THEM INTO SPECS, BUT THEN WHEN HE TESTED THE ALARMS VIA SETTING THE MAX AND MIN PAW THUMBWHEELS, THE VENTILATOR ONLY ALARMED WHEN THE MAP GOT TO 15. IT DID NOT MATTER WHERE THE THUMBWHEELS WERE SET AT, THE VENT ALARMED WHEN MAP GOT TO 15. HE SUSPECTS A FAULTY ALARM BOARD. CAREFUSION TECHNICAL SERVICES SENT A REPLACEMENT ALARM BOARD. PATIENT INVOLVEMENT UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72941 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1