BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREFUSION

    MDR report key: 5417313 · Received February 8, 2016

    Report

    Report Number
    2021710-2016-03012
    Event Type
    Malfunction
    Date Received
    February 8, 2016
    Date of Event
    April 22, 2014
    Report Date
    June 6, 2014
    Manufacturer
    CAREFUSION
    Product Code
    LSZ
    PMA / PMN Number
    P890057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MAIN HARNESS ASSEMBLY PN (B)(4) WAS REPLACED TO RESOLVE THIS ISSUE. NO FURTHER EVALUATION WAS NECESSARY.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS RECEIVED VIA AN EMAIL FROM CAREFUSION GERMANY 234 GMBH ON (B)(6) 2014. CAREFUSION (B)(4) 234 GMBH REPORTED THAT THIS UNIT WIRING HARNESS HAD A LOOSE CONTACT THAT CAUSED THE UNIT TO STOP. IT WAS ON A ON THE PATIENT AND THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75181 CAREFUSION VENTILATOR, HIGH FREQUENCY LSZ CAREFUSION 3100A

    Patients

    Seq Age Sex Outcome Treatment
    1