BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3902622 · Received May 9, 2014

    Report

    Report Number
    2249723-2014-00531
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP VERIFIED THE FAULT LOG. THE COMPANY REP REPLACED THE DRIVE ASSEMBLY (PART NUMBER 0104-00-0018). THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED AN AUTOFILL FAILURE AND A MAINTENANCE CODE #2 (DRIVE TRANSDUCER OFFSET FAILURE). THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282298 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1