BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872066 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00371
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    June 15, 2012
    Report Date
    June 18, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K63525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE VERIFIED THAT THE UNIT WOULD NOT SHUT DOWN. THE COMPANY REPRESENTATIVE REPLACED THE POWER SUPPLY ((B)(4)), AND TESTED THE IABP TO FACTORY SPECIFICATION. THE IABP 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 PATIENT, THE IABP UNIT WOULD NOT TURN OFF UNLESS UNPLUGGED AND BATTERY PULLED FROM THE UNIT. THE IABP WAS REPLACED AND THERAPY WAS INITIATED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234930 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other