BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFINE PRODUCT

    MDR report key: 2772220 · Received October 4, 2012

    Report

    Report Number
    2015691-2012-18396
    Event Type
    Malfunction
    Date Received
    October 4, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 11, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED AND A VISUAL AND FUNCTIONAL ANALYSIS WAS PERFORMED. WE RECEIVED A FLOTHRU DPT WITH STOPCOCKS AT BOTH ENDS OF THE DPT FOR EXAMINATION. THE DPT ZEROED AND SENSED PRESSURE ACCURATELY ON A PRESSURE MONITOR. ELECTRICAL TESTING SHOWED THAT THE DPT ELECTRONIC COMPONENTS WERE INTACT: BOTH INPUT AND OUTPUT IMPEDANCE WERE WITHIN SPECIFICATIONS. ZERO-OFFSET ALSO MET SPECIFICATION, PER THE INSTRUCTIONS FOR USE. CORROSION WAS OBSERVED AT THE CONTACT PLATES OF THE DPT CABLE CONNECTOR. IT APPEARED THAT THE CORROSION WAS CAUSED BY MOISTURE OR LIQUID (SALINE) DURING USE HAD CAUSED AN ELECTRICAL SHORT CONDITION WITH AN INABILITY TO SENSE PRESSURE. THE COMPLAINT WAS CONFIRMED, BUT THERE IS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT DEVICE HANDLING MAY HAVE CONTRIBUTED TO THE EVENT. NO ACTIONS WILL BE TAKEN AT THIS TIME. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE VALUE DISPLAYED WAS ABNORMALLY LOW ON THE FIRST DAY OF USE. THE ACTUAL VS. EXPECTED VALUES WERE NOT AVAILABLE. THE UNIT ZEROED WITHOUT PROBLEMS. IT COULD NOT BE CONFIRMED WHETHER THERE WAS ANY LEAKAGE OR IF THE WAVEFORM WAS NORMAL . NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFINE PRODUCT DISPOSABLE PRESSURE TRANSDUCER DXO EDWARDS LIFESCIENCES DR CSA3011Z_ ZK0097LT

    Patients

    Seq Age Sex Outcome Treatment
    1