BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 2053427 · Received March 17, 2011

    Report

    Report Number
    2021710-2011-00020
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K032451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CAREFUSION ISSUED A RETURN GOODS AUTHORIZATION (RGA) NUMBER TO THE FOREIGN DISTRIBUTOR FOR THE RETURN OF THE ALLEGED FAULTY MAIN PCBA FOR EVALUATION. ADDITIONALLY, A FOLLOW-UP REMINDER TO RETURN THE ALLEGED FAULTY MAIN PCBA WAS SENT TO THE FOREIGN DISTRIBUTOR. AS OF MARCH 16, 2011, THE ALLEGED FAULTY MAIN PCBA HAS NOT BEEN RECEIVED. ONCE THE MAIN PCBA HAS BEEN RECEIVED AND THE EVALUATION COMPLETED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. A REVIEW OF THE CAREFUSION COMPLAINT SYSTEM FOR THE PAST 90 DAYS DID NOT FIND ANY VERIFIED LIKE FAILURES, THUS AT PRESENT, CAREFUSION CONSIDERS THIS TO BE AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A CAREFUSION TECH SUPPORT SPECIALIST IN RESPONSE TO AN E-MAIL FROM THE DISTRIBUTOR IN (B)(4). "(B)(4) OBF [OUT OF BOX FAILURE] (B)(4)." "ALARM NO FUNCTION!." "(B)(4) (B)(6) 2010."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE/CBK CBK CAREFUSION VELA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA