BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE PRESSURE TRANSDUCER CABLE

    MDR report key: 3980737 · Received August 5, 2014

    Report

    Report Number
    2015691-2014-01785
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXO
    PMA / PMN Number
    K925638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE CABLE ASSEMBLY WAS RECEIVED FOR PRODUCT EVALUATION. THE CABLE WAS TESTED PER (FATU) FINAL ACCEPTANCE TEST UNIT AND IT PASSED THE FUNCTIONAL TEST. THE CABLE WAS ALSO TESTED WITH THE CONTINUITY PASS RESISTANCE TEST AND PASSED. THERE WAS NO PHYSICAL DAMAGE THAT WAS NOTED ON THE CABLE. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE DEVICE HISTORY RECORD IS UNAVAILABLE. THE REPORTED ISSUE COULD NOT BE CONFIRMED. NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT WAS PRE-BYPASS DURING AN OPEN HEART PROCEDURE. THE PREOPERATIVE CUFF READINGS WERE 130/140 SYSTOLIC. THE INITIAL ARTERIAL BP READINGS WERE 73/40 SYSTOLIC. WITH INDUCTION THE BLOOD PRESSURE DROPPED TO 50/55 SYSTOLIC. AGGRESSIVE MEASURES WERE TAKEN. AN IABP WAS INSERTED. THE PRESSURE READING WAS 190 SYSTOLIC. THE DPT WAS LOW, ARMS WERE TUCKED, UNKNOWN CUFF BLOOD PRESSURE. THE ARTERIAL WAVEFORM WAS ¿NEVER ABNORMAL.¿ THE PX1800 CABLE WAS CHANGED FOR ANOTHER AND THE PRESSURE READINGS WERE IN THE 150¿S SYSTOLIC. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457809 DISPOSABLE PRESSURE TRANSDUCER CABLE TRUWAVE REUSABLE CABLE DXO EDWARDS LIFESCIENCES 896019021 4309721

    Patients

    Seq Age Sex Outcome Treatment
    1