BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2191860 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00127
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    June 17, 2011
    Report Date
    June 17, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATASCOPE'S SERVICE UNIT REPLACED THE MAIN PRINTED CIRCUIT BOARD ((B)(4)). THE SYSTEM WAS TESTED TO FACTORY SPECS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE MAIN BOARD WAS RETURNED TO THE FACTORY FOR EVAL. ENGINEERING CONFIRMED THAT A CAPACITOR (C122) HAD FAILED, CAUSING THE REPORTED ODOR. THERE WAS NO EVIDENCE OF FIRE. WE HAVE NOT RECEIVED ANY RELATED COMPLAINTS; THEREFORE, THIS IS CONSIDERED AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE PUMP SHUT DOWN AND THERE WAS A SMELL OF FIRE. THEY REPLACED THE PUMP WITH ANOTHER, AND THE PROCEDURE WAS COMPLETED. THE PT WAS IN STABLE CONDITION, AND NO 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