BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2862156 · Received November 29, 2012

    Report

    Report Number
    2249723-2012-00416
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 7, 2012
    Report Date
    October 8, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S BIOMED REPLACED THE POWER SUPPLY. THE IABP WAS TESTED BY THE BIOMED AND RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP SHUTDOWN. THE PATIENT SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK