BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3902589 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00532
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE BATTERIES (PART NUMBER 0146-00-0039. THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE ORIGINAL BATTERIES WERE SENT TO MEDWATCH REPAIR CENTER, NEW JERSEY FOR EVAL. THE TESTS CONCLUDED THAT THE BATTERIES WERE 3 YEARS OLD (DATE CODE ON BATTERIES IS FEBRUARY 06, 2009) AND DID NOT MEET THE ACCEPTANCE CRITERIA OF MINIMUM 2 HOURS RUN TIME. IN CONCLUSION, THE IABP SHUTDOWN WAS ATTRIBUTED TO THE BATTERIES, THAT WERE AT THE SHELF LIFE EXPECTANCY. IT IS STATED IN THE CS300 MANUAL TO REPLACE BATTERIES AS REQUIRED. BATTERIES SHOULD BE REPLACED AFTER 100 FULL DISCHARGE CYCLES, AT NO MORE THAN THREE (3) YEARS INTERVALS. INTERNAL FILE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP SHUTDOWN WHEN THE UNIT WAS UNPLUGGED. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282283 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1