BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOHELP SYSTEM

    MDR report key: 4544302 · Received February 23, 2015

    Report

    Report Number
    3008355164-2015-00027
    Event Type
    Injury
    Date Received
    February 23, 2015
    Date of Event
    December 14, 2011
    Report Date
    December 28, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VSAT (VENOUS OXYGEN SATURATION) WAS LOW AND UNABLE TO RECALIBRATE WHILE O A PT. WHEN A CALIBRATION WAS COMPLETED THE HCT LEVELS WERE HIGH AND COMPARED TO THE NORMAL READINGS THE USER WAS EXPECTING. AS A PRECAUTION THE VENOUS PROBE AND CABLE WERE REPLACED. ACCORDING TO THE PERFUSIONIST AT THE ACCOUNT, THEY (THE LOW SATURATION VALUES) WERE VERIFIED WITH LAB RESULTS. A SERVICE TECHNICIAN TESTED THE PROBE TO FACTORY SPECIFICATIONS. THE VENOUS PROBE REPORTED WAS IN USE WITH CARDIOHELP-I CONSOLE MODEL NUMBER 70104.8012, SERIAL NUMBER (B)(4). BOTH THE PROBE AND CONSOLE ARE COMPONENTS OF THE CARDIOHELP SYSTEM CLEARED UNDER 510(K) #K102726. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125613 CARDIOHELP SYSTEM DTQ MAQUET CARDIOPULMONARY AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R