BEUDAMED
    FDA Adverse Event Summary report: N

    SYSTEM98XT

    MDR report key: 1982435 · Received January 31, 2011

    Report

    Report Number
    2249723-2010-00276
    Date Received
    January 31, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 8, 2010
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THE "ELECTRICAL TEST FAILURE CODE #53" (SHUTTLE TRANSDUCER OFFSET FAILURE). THE UNIT PASSED AN ELECTRICAL SAFETY TEST. A FUNCTIONAL CHECK WAS PERFORMED AND THE UNIT PUMPED FOR MORE THAN 70 HOURS WITHOUT ANY SUDDEN POWER OFF. THE UNIT WAS TESTED TO FACTORY SPECIFICATION. THE EVENT IS UNDER ADDITIONAL INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT SUDDENLY SHUTDOWN. THE CUSTOMER RESTARTED THE UNIT AND IT PUMPED FOR A FEW MINS AND, THEN THE UNIT SHUTDOWN AGAIN. THE PT WAS SWITCHED TO ANOTHER UNIT AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM98XT INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. SYSTEM98XT

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK