BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET/DATASCOPE

    MDR report key: 2220432 · Received August 18, 2011

    Report

    Report Number
    MW5021799
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 10, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011 (B)(4): PT ADMITTED POSSIBLE MI, ACUTE PULMONARY EDEMA AND INTUBATION. UNDERWENT AN EMERGENT CARDIAC CATHETERIZATION, IABP, MECHANICAL VENTILATION AND TRANSFERRED TO ICU POST PROCEDURE. ON (B)(6) 2011 (B)(4): THE IABP AUDIBLE ALARM SOUNDS OFF AND "LOW HELIUM" MESSAGE IS NOTED. NURSE REVIEWS THE "HELP" SCREEN ALARM/ADVISORY. THE CORRECTIVE ACTIONS ON THE HELP SCREEN RECOMMENDS TO OPEN HELIUM TANK AND REPLACE THE HELIUM TANK. RN PROCEEDED TO CONTACT THE PERFUSIONIST TO HELP REPLACE THE TANK AND FAILED TO CHECK THAT THE HELIUM TANK WAS OPEN (HELIUM TANK WAS CLOSED). CONCURRENTLY, PT WENT ASYSTOLE AND CODE BLUE WAS CALLED. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET/DATASCOPE DATASCOPE IABP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other