BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTILATOR, HIGH FREQUENCY

    MDR report key: 5426933 · Received February 10, 2016

    Report

    Report Number
    2021710-2016-03101
    Event Type
    Malfunction
    Date Received
    February 10, 2016
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 CUSTOMER WAS SENT A REPLACEMENT 3100B DISPOSABLES SHIP KIT, BOX OF 4-850, PN 11744-850K, BELLOWS/WATER TRAPS PN766897, CAP DIAPHRAGMS PN766896 AND CIRCUITS PN 773996. AS OF THIS DATE THE PARTS HAVE NOT BEEN RECEIVED FOR EVALUATION. WHEN THEY HAVE BEEN RECEIVED AND EVALUATED A SUPPLEMENT WILL BE FILED.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN A RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE ON (B)(6) 2014. THE CUSTOMER CALLED TO REPORT THAT THIS VENT WOULDN'T PRESSURIZE TO SPECS (PATIENT CIRCUIT CALIBRATION - 38CMH2O WITH PR3 MAXED OUT). THEY ALSO NOTICED THAT THERE WAS A HIGH PITCHED WHISTLING NOISE. THERE WAS NO INDICATION OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86954 VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100B

    Patients

    Seq Age Sex Outcome Treatment
    1