BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1013229 · Received March 12, 2008

    Report

    Report Number
    6000002-2008-06162
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 14, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT TUBING WAS BROKEN WITH MARKS (2 BLUE AND 1 BLACK).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE MONITOR DRS EDWARDS LIFESCIENCES PX260 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN