BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 3980260 · Received July 2, 2014

    Report

    Report Number
    2249723-2014-00671
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    July 23, 2012
    Report Date
    July 23, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THAT THERE WAS A MONO TONE ALARM AND NO DISPLAY. THE COMPANY REPRESENTATIVE REPLACED THE MAIN PROCESSOR PCB (PART NUMBER 0670-00-1152E), THE REAR PANEL (PART NUMBER 0380-00-0435), THE LABEL S/N (B)(4) ENGLISH (PART NUMBER 0334-00-2594-01), THE LABEL SAFETY DISK WARNING (PART NUMBER 0334-00-1121), THE LABEL REAR PANEL I/O ENGLISH (PART NUMBER 0334-00-2602-01), THE LABEL AC MAIN ENGLISH (PART NUMBER 0334-00-2603-01), THE LABEL FUSE REPLACEMENT ENGLISH (PART NUMBER: 0334-00-2611-01), AND THE LABEL HE (PART NUMBER 0334-00-2618). 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 PRIOR TO USE ON A PT THE "IABP ALARMED AND THEN DISPLAYED WENT OUT- PERMANENTLY". THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387507 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1