BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DISPOSABLE PRESSURE TRANSDUCER

    MDR report key: 2252183 · Received September 16, 2011

    Report

    Report Number
    2015691-2011-16182
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, AT THIS TIME THE COMPLAINT COULD NOT BE CONFIRMED WITHOUT THE PRODUCT. A SUPPLEMENTAL REPORT WILL BE SENT WITH THE FINAL INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 1

    ONE SINGLE DPT KIT WAS RETURNED FOR EVALUATION WITHOUT THE PRESSURE TUBING. PRIMING SOLUTION WAS VISIBLE INSIDE THE KIT. THE SENSOR PAD APPEARED INTACT. THE ACTUAL COMPLAINT ISSUE OF "FILTRATION OF FLUID THROUGH THE SENSOR" WAS NOT CONFIRMED; HOWEVER, MULTIPLE CRACKS WERE IDENTIFIED AROUND THE FEMALE LUER BODY. WHILE THESE TYPES OF CRACKS CAN LEAD TO LEAKAGE, THE RISK FOR PATIENT INJURY IS CONSIDERED REMOTE. AN INVESTIGATION IS ALREADY OPEN TO DETERMINE THE ROOT CAUSE OF CRACKS AT THE FEMALE LUER AND CORRECTIVE ACTIONS WILL BE IMPLEMENTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT THERE WAS A FILTRATION OF FLUID THROUGH THE SENSOR. IT FURTHER STATED AND CLARIFIED THAT (FILTRATION) INDICATED A LEAK IN THE ASSEMBLY OF THE SENSOR OF THE DEVICE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX DISPOSABLE PRESSURE TRANSDUCER PRESSURE MONITORING KIT WITH TRUWAVE DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR PX260 58907150

    Patients

    Seq Age Sex Outcome Treatment
    1