BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 2862159 · Received November 29, 2012

    Report

    Report Number
    2249723-2012-00382
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 20, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY REPRESENTATIVE EVALUATED THE IABP. AS OF THE DATE OF THIS REPORT, WE HAVE BEEN UNABLE TO DUPLICATE THE REPORTED PROBLEM. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, AFTER TWO DAYS OF THERAPY, THE IABP WENT INTO STANDBY WITH NO ALARM. DURING THIS TIME, THE PRINTER DID NOT WORK. THE CUSTOMER PRESSED THE "START" KEY AND THE "IAB FILL" KEY BUT THE IABP DID NOT RESPOND. OTHER KEYS WERE WORKING. RECYCLING POWER DID NOT CORRECT THE ISSUE. THE PT DID NOT REQUIRE ADDITIONAL THERAPY, AND WAS WEANED FROM THE IABP. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK