BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 3932995 · Received July 14, 2014

    Report

    Report Number
    2015691-2014-01588
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    December 2, 2013
    Report Date
    May 5, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATION AT THE TIME OF RELEASE. THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT A PRODUCT RETURN, NOR COULD POTENTIAL CONTRIBUTING FACTORS BE IDENTIFIED. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARTERIAL LINE BECAME DETACHED ON ONE SIDE NEAR THE TRANSDUCER. THERE WAS NO HARM OR INJURY TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410683 PHOENIX DISPOSABLE PRESSURE TRANSDUCER PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP JR. DXO EDWARDS LIFESCIENCES DR VMP426PX 59501161

    Patients

    Seq Age Sex Outcome Treatment
    1