BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3817536 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00285
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    December 23, 2013
    Report Date
    December 23, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE SOLENOID DRIVER BOARD, PN: (B)(4); SAFETY DISK, PN: (B)(4); 1500 HR KIT, PN: (B)(4). 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 DURING A PREVENTIVE MAINTENANCE ON THE IABP, THEY OBSERVED THAT THE IABP COULD NOT BE PASS BLOODBACK TEST AND WANTED THE SERVICE REP TO COMPLETE THE PREVENTATIVE MAINTENANCE. NO PT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185453 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1