BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4093199 · Received August 21, 2014

    Report

    Report Number
    2249723-2014-01172
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    May 22, 2012
    Report Date
    May 22, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BIOMED AT THE HOSPITAL PERFORMED A PM ON THE PUMP, CHANGED THE HELIUM TANK AND O-RING AND PERFORMED A LEAK TEST. THE PUMP WAS PERFORMING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    THE COMPANY CLINICAL REPRESENTATIVE REPORTED THAT DURING HANDS-ON TIME OF CLASS, THE PUMP WAS TURNED ON AND THE HELIUM TANK ICON SHOWED EMPTY. A NEW HELIUM TANK WAS OBTAINED. AFTER SEVERAL ATTEMPTS TO CHANGE THE TANK, THE HELIUM TANK ICON STILL SHOWED EMPTY AND "AUTOFILL FAILURE - NO HELIUM" ON SCREEN. HELIUM WAS HEARD HISSING A COUPLE OF TIMES IN THE PROCESS OF CHANGING THE TANK, SO IT WAS NOT EMPTY. THEY WERE UNABLE TO USE THE PUMP FOR TRAINING DUE TO INABILITY TO OBTAIN A HELIUM TANK CONNECTION WITH PUMP. IT WAS NOTED THAT THE SERVICE STICKER ON THE CRM/SAFETY DISK EXPIRED IN JANUARY OF 2012. A SECOND PUMP WAS OBTAINED FOR CLASS TRAINING. THE PUMP WAS TAKEN TO THE BIOMED DEPARTMENT BY ANNE PETERSON - INTERIM DIRECTOR OF CRITICAL CARE. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506533 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1