BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM DEFIND PRODUCT

    MDR report key: 2864557 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18811
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    EDWARDS LIFESCIENCES DR
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BP VALUES WHICH WERE DISPLAYED ON AUTOMATED SPHYGMOMANOMETER AND TRANSDUCER WERE DIFFERENT. ADDITIONAL INFORMATION (B)(4) 2012: SYSTOLIC PRESSURE SHOWED 180 MMHG ON THE AUTOMATED SPHYGMOMANOMETER AND 90 MMHG ON DPT . THE SHAPE OF THE WAVEFORM ON THE MONITOR WAS NORMAL. IT WAS CONFIRMED VIA TRUCIAL THAT THE VALUE AND THE WAVEFORM MATCHED. THERE WERE NO ERROR MESSAGES NOTED AND ALSO, NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION (B)(4) 2012: THEY REPLACED THE CABLE WITH ANOTHER CABLE AND THE SITUATION WAS IMPROVED. THEN THEY THOUGHT THE CABLE CAUSED THE SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM DEFIND PRODUCT TRANSDUCER, PRESSURE, CATHETER TIP DXO EDWARDS LIFESCIENCES DR TC0817SA_

    Patients

    Seq Age Sex Outcome Treatment
    1