BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3873768 · Received May 2, 2014

    Report

    Report Number
    2249723-2014-00551
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Report Date
    October 15, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE DID NOT FIND ANY ISSUE WITH THE PUMP. HE COMPLETED PREVENTIVE MAINTENANCE AND PERFORMED FULL CALIBRATION, FUNCTIONAL TEST, AND SAFETY CHECK TO FACTORY SPECIFICATION. THE PUMP WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE IABP GENERATED A "RAPID GAS LOSS" ALARM. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264059 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1