BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 2961166 · Received January 30, 2013

    Report

    Report Number
    2249723-2013-00009
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS UNDER INVESTIGATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON THE PT, THE IABP DISPLAY WENT BLACK AND THE IABP DID NOT GENERATE ANY MORE SOUND. THE CUSTOMER ASSUMED THAT THE IABP SHUTDOWN. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41324 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI