BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV1000A PLATFORM SYSTEM

    MDR report key: 14092334 · Received April 13, 2022

    Report

    Report Number
    2015691-2022-05031
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    March 18, 2022
    Report Date
    May 25, 2022
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXG
    UDI-DI
    00690103189650
    PMA / PMN Number
    K100709
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. WHEN IT ARRIVES AND THE PRODUCT EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE HISTORY REVIEW WAS COMPLETED AND ALL INSPECTIONS PASSED WITH NO NON-CONFORMANCES.

    Additional Manufacturer Narrative · 0

    ONE EV1000 DEVICE WAS RECEIVED FOR PRODUCT EVALUATION. A VISUAL INSPECTION DID NOT FIND ANY VISIBLE PHYSICAL DAMAGE. THE PANEL AND DATA BOX BOOTED UP AND CONNECTED ON BOTH PANEL ETHERNET PORTS WITHOUT ISSUE. THE TOUCH SCREEN IS FUNCTIONAL. THE DATA BOX PASSED FUNCTIONAL TEST. THE SYSTEM WAS CONNECTED TO A MINI-SIM. AP AND CVP WAVEFORMS WERE ABLE TO BE ZEROED AND WERE STABLE FOR HALF AN HOUR AS WAS THE BT. THERE WAS NO DEFECT FOUND IN THE UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE EV1000 SYSTEM THAT WHEN CLEARSIGHT STARTS THE SYSTEM GETS TO A GOOD PHYSIOCAL CONTINUES FOR A WHILE AND THEN COMPLETELY STOPS READING AND BEGINS TO RECALIBRATE. IT ACTED AS IF THE CUFF WAS LEAKING BUT THEY SWITCHED OUT SEVERAL CUFFS AND HAD THE SAME OCCURRENCE. THEY ALSO REPORTED THE BLOOD PRESSURES BEING VERY OFF. THE INACCURATE VALUES WERE IN COMPARISON TO A BRACHIAL CUFF. THE MAPS WERE OFF BY MORE THAN 20MMHG THUS MAKING SYS AND DIA EVEN FURTHER APART. CLEARSIGHT WAS READING CLINICALLY LOW WHILE THE CUFF WAS NORMAL. THERE WERE NO CLINICAL SIGNS FOR HYPOTENSION.THIS WAS DURING USE. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165340 EV1000A PLATFORM SYSTEM EV1000A PLATFORM SYSTEM DXG EDWARDS LIFESCIENCES EV1000A 00690103189650

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown