BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3100A PRODUCT

    MDR report key: 5417391 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-03015
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS (FA) LAB RECEIVED AN ALARM BOARD ASSEMBLY (3100A). THE UNIT WAS INSTALLED INTO A KNOWN GOOD HFOV MODEL 3100A. FA PERFORMED AN ALARM FUNCTION CHECKOUT PER THE SERVICE MANUAL; THE CHECKOUT FAILED. THE ALARM SOUNDS OF 45 SEC SILENCE BUTTON WAS ACTIVATED LED ON, BUT COULD NOT BE TURNED OFF. THE FAILURE WAS FOUND FROM U13 (IC-555 TIME DELAY MONO) WHICH HAD NO OUTPUT SIGNAL AT PIN U13.3. INPUT 13.2 (TRIGGER) WAS 15V-0V (SQUARE WAVE). THE COMPLAINT ALLEGATION "ALARM BOARD FAILED 45 SEC BUTTON DIDN¿T WORK WOULDN¿T UNABLE THE ALARM¿ WAS DUPLICATED DUE TO A DEFECTIVE IS U13 (IC-555 TIME DELAY MONO).

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH 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. THE UNIT WAS RETURNED TO CAREFUSION AND THE ISSUE WAS ISOLATED TO THE FAN, POWER SUPPLY AND FRONT PANEL. THE UNIT WAS TESTED DID MEET MANUFACTURER SPECIFICATIONS AND WHEN COMPLETED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS RECEIVED FROM CAREFUSION FSE ON (B)(6) 2014. THE CAREFUSION FSE TO REPORT THAT THIS UNIT HAD 12K PM IN (B)(6). THE DDI DISPLAY WAS NOT SHOWING UP. THE DDI BOARD AND DRIVER WERE REPLACED. WHEN INSTALLING THE NEW DRIVER THE ALARM VOLTAGES ARE OFF AND THE POWER SUPPLY WAS NOT WORKING. A POWER SUPPLY AND MAIN WIRING HARNESS WAS SENT BUT THE +5, +15 AND -15 VOLTAGES ARE ALL OFF AND CANNOT GET THEM INTO SPECIFICATION. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75843 3100A PRODUCT VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1