BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100

    MDR report key: 4241318 · Received September 4, 2014

    Report

    Report Number
    2249723-2014-00677
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    February 2, 2012
    Report Date
    February 2, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THAT THE AUTOFILL LUER FITTING HOSE BROKEN OFF. AUTOFILL HOSE AND DRAIN HOSE WERE KINKED AND VERY DISCOLORED. THE COMPANY REPRESENTATIVE REPLACED THE AUTOFILL LUER FITTING AND TUBING AND DRAIN TUBING ASSEMBLY. 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 UNIT, THE UNIT GENERATED AN AUTOFILL FAILURE ALARM. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542156 CS100 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1