BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3871937 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00407
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 19, 2013
    Report Date
    March 19, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EKG CABLE WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP WOULD NOT ACQUIRE AN EKG. THEY USED THE PRESSURE TRIGGER TO INITIATE THE PUMPING AND REPLACED THE EKG CABLE. THE PUMP RECOGNIZED AND ACQUIRED THE EKG. THE THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236122 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1