BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING SET

    MDR report key: 3813407 · Received May 15, 2014

    Report

    Report Number
    2015691-2014-01155
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 19, 2014
    Report Date
    April 23, 2014
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE DPT ¿ VAMP FLEX KIT WAS RECEIVED. THE EXAMINATION REVEALED THAT BOTH THE ARTERIAL AND CVP DPTS ZEROED AND SENSED PRESSURE ACCURATELY ON THE PRESSURE MONITOR. THE READING WAS STABLE. THE ELECTRICAL TESTING SHOWED THAT THE DPT ELECTRONIC COMPONENTS WERE INTACT BECAUSE BOTH THE INPUT AND OUTPUT IMPEDANCES WERE WITHIN SPECIFICATIONS. HOWEVER, THERE WAS GREEN CORROSION THAT WAS DETECTED FROM BOTH THE DPT CABLE CONNECTORS. THE CORROSION OCCURRED AT THE MAJORITY OF THE CONTACT PLATES OF BOTH THE CABLE CONNECTORS. THIS GREEN CORROSION SUGGESTED THAT MOISTURE HAD GOTTEN ONTO THE CONNECTOR PINS. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED. THE REPORTED EVENT OF INACCURATE PRESSURE READING WAS NOT ABLE TO BE REPLICATED IN THE LAB. THERE IS NO INDICATION OF A MANUFACTURING DEFECT THAT WAS NOTED DURING THE ANALYSIS. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    PT WAS NOTED TO BE ON VASOPRESSORS. A DISCREPANCY WAS NOTED BETWEEN THE ARTERIAL BLOOD PRESSURE 97/79, AND THE NIBP BLOOD PRESSURE 70/30. CUSTOMER STATED THAT THE DPT WAS ZEROED PROPERLY AND IN THE CORRECT POSITION. ARTERIAL WAVEFORM WAS PRESENT. DPT WAS CONSEQUENTLY CHANGED OUT. NO PATIENT INJURY WAS REPORTED. NO FURTHER CLINICAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292036 PRESSURE MONITORING SET PRESSURE MONITORING SET DXO EDWARDS LIFESCIENCES DR T005021M

    Patients

    Seq Age Sex Outcome Treatment
    1