BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4001160 · Received July 16, 2014

    Report

    Report Number
    4001160
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MALE PATIENT HAD BEEN EXPERIENCING ANGINAL TYPE CENTRAL CHEST PAIN. HE UNDERWENT CORONARY ARTERIOGRAPHY, WHICH DEMONSTRATED SEVERE CORONARY ARTERY DISEASE. PATIENT BEING CARE FOR IN CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU). MAQUET INTRA-AORTIC BALLOON PUMP (IABP) STARTED ALARMING "MAINTENANCE CODE 2 REQUIRED" THEN IABP STOPPED AND ALARMED "SYSTEM FAILURE." NURSE SWITCHED OUT IABP AND NOTIFIED BIOMEDICAL SERVICES. NO UNTOWARD PATIENT EFFECTS.DURING POWER-UP TESTING, RECEIVED "SYSTEM OKAY," AND NO FAILURES. SYSTEM PASSES ALL FUNCTIONAL TESTS AND CALIBRATIONS. SYSTEM DIAGNOSTICS REVEALED AN ELECTRICAL TEST FAIL CODE 58 AND AUTOFILL FAILURES THAT INDICATE ATMOSPHERIC TRANSDUCER CALIBRATION FAILURE. ATMOSPHERIC TRANSDUCER READS 746 MMHG, WHICH IS CONCURRENT WITH ACTUAL ATMOSPHERIC PRESSURE IN THE AREA. SYSTEM OPERATES TO FACTORY SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416657 CS300 SYSTEM, BALLOON, INTRA-AORTIC DSP MAQUET CARDIOVASCULAR D998-00-3023-53 *

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR