BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 4213128 · Received August 4, 2014

    Report

    Report Number
    2249723-2014-01140
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP OBSERVED THAT THE PRESSURE HOSE AND CONNECTOR ARE CRACKED. THE COMPANY REP REPLACED THE FOLLOWING COMPONENTS: BACK PRESSURE REGULATOR (PART NUMBER 0103-00-0511), COMPRESSOR (PRESSURE) HOSE (PART NUMBER 0004-00-0068), PNEUMATIC COUPLER (PART NUMBER 0103-00-0373) AND SCREW LABEL CONCEALMENT (PART NUMBER 0334-00-1666). THE COMPANY REP PERFORMED PREVENTIVE MAINTENANCE AND REPLACED SAFETY DISK (PART NUMBER 0997-00-0985-01) AND 5000 HOUR PM KIT (0040-00-0147). THE COMPANY REP PERFORMED CALIBRATION, FUNCTIONAL TESTS AND SAFETY CHECKS. THE UNIT MET FACTORY SPECS AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    DURING A PREVENTIVE MAINTENANCE, THE COMPANY REP OBSERVED THAT THE REGULATOR TEST RESULTS AND PRESSURE PERFORMANCE TEST RESULTS GENERATED LOW OUT OF SPEC RESULTS. THE REGULATOR TEST SPECS ARE 375MMHG TO 413MMHG; THE RESULT WAS APPROX 250MMHG. THE AVERAGE PRESSURE PERFORMANCE TEST SPECS ARE 300MMHG TO 413MMHG; THE RESULT WAS 75MMHG. NO PT WAS INVOLVED. DURING THE SAME PREVENTIVE MAINTENANCE, THE COMPANY REP OBSERVED THAT THERE WAS A SYSTEM FAILURE ALARM DURING AUTOFILL. REFER TO MDR 2249723-2014-01141 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455642 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1