BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4047039 · Received August 26, 2014

    Report

    Report Number
    2249723-2014-01262
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Date of Event
    July 11, 2013
    Report Date
    July 26, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE VIDEO RECEIVER BOARD (PART NUMBER 0670-00-0736), CABLE DISPLAY TO VIDEO RECEIVER BOARD (PART NUMBER 0012-00-1429) AND THE COILED CABLE (PART NUMBER 0012-00-1422). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A ROUTINE CHECK OF THE IABP, THE MONITOR DISPLAY WOULD INTERMITTENTLY SHUT OFF. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518343 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1