BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS AQUARIUS SYSTEM

    MDR report key: 1366139 · Received January 30, 2009

    Report

    Report Number
    6000002-2009-09773
    Event Type
    Malfunction
    Date Received
    January 30, 2009
    Date of Event
    May 21, 2008
    Report Date
    June 5, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KDI
    PMA / PMN Number
    K070320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: DRIFT OF THE MEMSCAP TRANSDUCER.

    Description of Event or Problem · 1

    REPORTEDLY, THE MEMSCAP PRESSURE TRANSDUCER IS OUT OF SPECIFICATION, UNABLE TO BE CALIBRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS AQUARIUS SYSTEM HEMOFILTRATION SYSTEM KDI EDWARDS LIFESCIENCES GEF09600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK