BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1032419 · Received April 15, 2008

    Report

    Report Number
    6000002-2008-06376
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 7, 2008
    Report Date
    March 10, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CRACK FOUND ON THE RESERVOIR SYRINGE OF THE VAMP FLEX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE MONITOR DRS EDWARDS LIFESCIENCES 597507003 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK