BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 2191854 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00101
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 6, 2011
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP WAS NOT ABLE TO DUPLICATE THE REPORTED FAILURE. HE FOUND THE "SYSTEM FAILURE" FAULT CODE 65 (IABP SHUTDOWN) IN THE DIAGNOSTICS AND THE "ELECTRICAL TEST FAIL CODE #53" (SHUTTLE TRANSDUCER OFFSET FAILURE). THE COMPANY REP REPLACED THE DRIVE MANIFOLD (PART NUMBER 0104-00-0018) AND THE PRESSURE TRANSDUCER (PART NUMBER 0682-00-0076-01). THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE SERVICE HISTORY OF THE DEVICE DOES NOT INDICATE ANY SYSTEMIC ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING TRANSPORT WITHIN THE HOSPITAL, WHILE THE UNIT WAS IN USE ON A PT, THE UNIT DISPLAYED "SYSTEM FAILURE" WITH "ELECTRICAL TEST FAILURE CODE #53" ALARM. THE UNIT WAS REPLACED AND THERAPY WAS CONTINUED. 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