BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4030561 · Received July 29, 2014

    Report

    Report Number
    2249723-2014-01031
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    September 22, 2011
    Report Date
    September 22, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE COMPRESSOR MOTOR ASSEMBLY (PART # 0102-00-0001), ECG CABLE ASSEMBLY (PART # 0012-00-0976) AND GROMMET (PART # 0348-01-0012) WERE REPLACED. THE MOTOR SPEED WAS CALIBRATED. THE COMPANY REP PERFORMED FUNCTIONAL AND SAFETY TESTS. THE UNIT MET FACTORY SPECS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE UNIT WAS IN USE ON A PT, THE UNIT GENERATED A LOW VACUUM AND ELECTRICAL TEST FAILS CODE #50 (MOTOR SPEED OUT OF SPEC) ALARMS. 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
    442617 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1