BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5419119 · Received February 9, 2016

    Report

    Report Number
    2021710-2016-03050
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    July 7, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 POTENTIOMETER PN (B)(4) AND A REPLACEMENT PRESSURE TRANSDUCER PN (B)(4). 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 HAS AN INTERMITTENT PROBLEM WITH THE AMPLITUDE. ALL OF A SUDDEN THE AMPLITUDE WILL INCREASE TO 38 AND THEN COME BACK DOWN TO 20 WITHOUT ANYONE TOUCHING IT. THERE WAS NOT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82572 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1