BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3817578 · Received March 28, 2014

    Report

    Report Number
    2249723-2014-00275
    Event Type
    Malfunction
    Date Received
    March 28, 2014
    Date of Event
    September 4, 2013
    Report Date
    September 4, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THAT THE POWER CORD WAS DAMAGED. THE COMPANY REPRESENTATIVE REPLACED THE POWER CORD (PART NUMBER 0012-00-0886-01). 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 ROUTINE CHECK OF THE IABP, THE CUSTOMER OBSERVED THAT THE POWER CORD WAS DAMAGED. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185384 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1