BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3902604 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00534
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 2, 2012
    Report Date
    April 3, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE FOUND ONE BATTERY LEAKED AND THE POWER SUPPLY WAS NOT CHARGING. THE COMPANY REPRESENTATIVE REPLACED THE BATTERIES (PART NUMBER 0146-00-0039) AND POWER SUPPLY (PART NUMBER 0146-00-0039) AND POWER SUPPLY (PART NUMBER 0014-00-0033E05). AFTER THE REPAIR, THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE ORIGINAL BATTERIES AND THE POWER SUPPLY WERE SENT TO (B)(4) FOR EVALUATION. THE EXTENSIVE TESTS ON POWER SUPPLY CONCLUDED THAT THERE WAS NO ISSUE WITH THE POWER SUPPLY. NO EVALUATION WAS PERFORMED ON THE BATTERIES AS THE BATTERIES WERE FOUR AND HALF YEARS OLD ((B)(4)). IT IS STATED IN THE CS100 MANUAL TO REPLACE BATTERIES AS REQUIRED. BATTERIES SHOULD BE REPLACED AFTER 100 FULL DISCHARGE CYCLES, AT NO MORE THAN THREE YEARS INTERVALS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP RAN ONLY FOR TWO MINUTES WHEN THEY WERE PREPARING FOR A TRANSPORT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282285 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1