BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)

    MDR report key: 5426490 · Received February 10, 2016

    Report

    Report Number
    2021710-2016-03076
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    November 7, 2013
    Report Date
    November 7, 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). THE CAREFUSION TECHNICAL SUPPORT SPECIALIST IN CONJUNCTION WITH THE END USER HAVE IDENTIFIED THAT A FAULTY CAP/DIAPHRAGMS (P/N 766896) AS MOST LIKELY THE ROOT CAUSE IN THIS ALLEGED EVENT. NO EVALUATION IS NEEDED AS THIS IS A KNOWN EVENT AND HAS BEEN ADDRESS WITH AN INTERNAL ACTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH CAP DIAPHRAGMS 766896. CUSTOMER, EXPLAINS THAT THEY HAVE BEEN FINDING MANY CAP DIAPHRAGMS THAT FALL APART. HE EXPLAINS THAT HE USUALLY CAN GET THE TOP LUER TO SNAP INTO PLACE, BUT THESE CAPS SEEM DO NOT SNAP TOGETHER AND LOCK INTO PLACE VERY WELL. THEY END UP FALLING APART THUS FAILING THE PATIENT CIRCUIT CALIBRATION. HE HAS KEPT ONE SET FROM LOT 0000507628 THAT HE CAN SEND BACK TO US. CAREFUSION TECHNICAL SUPPORT SPECIALIST, EXPLAINED TO HIM ABOUT CAP DIAPHRAGM ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86937 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV) VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1