BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3031027 · Received March 28, 2013

    Report

    Report Number
    2249723-2013-00021
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 24, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE PRESSURE REGULATOR (PART NUMBER: (B)(4)). THE IABP WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER'S THIRD PARTY BIOMED REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP GENERATED A "HIGH DRIVE PRESSURE" ALARM. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128693 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI