BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 2191862 · Received July 29, 2011

    Report

    Report Number
    2249723-2011-00128
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP WAS UNABLE TO CONFIRM THE CUSTOMER'S REPORT OF A MAINTENANCE REQUIRED CODE 2 (DRIVE TRANSDUCER OFFSET FAILURE), OR THAT THE UNIT HAD SHUT DOWN. HE DID DETERMINE THAT THERE WAS EXCESSIVE CONDENSATION IN THE FILL LINES. HE PURGED THE LINES AND REPLACED THE CONDENSATE REMOVAL MODULE (PART NUMBER (B)(4)). THE UNIT WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A REVIEW OF THE DEVICE'S SERVICE HISTORY DOES NOT INDICATE ANY SYSTEMIC ISSUES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT DISPLAYED "MAINTENANCE REQUIRED CODE 2" AND THE UNIT SHUTDOWN. 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 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK