BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 1374039 · Received February 13, 2009

    Report

    Report Number
    6000002-2009-09863
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 13, 2009
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DRS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HAS NOT BEEN RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    Z SITE CONNECTION PARTS WERE DETACHED AFTER USING FOR 8 HOURS. EVALUATION ONLY. (1/21/2009 ADDITIONAL INFORMATION: SALES REP REPORTED THAT THE DEVICE WAS DISCARDED AT THE HOSPITAL.) NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DISPOSABLE PRESSURE MONITOR DRS EDWARDS LIFESCIENCES 600380081 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other