BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 3980489 · Received June 5, 2014

    Report

    Report Number
    2249723-2014-00874
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE OBSERVED THAT THE BLOOD DETECTOR OF THE IAP COULD NOT BE CALIBRATED. HE ALSO OBSERVED THAT THE DOPPLER DOOR HINGE WAS BROKEN. THE COMPANY REPRESENTATIVE REPLACED THE BLOOD DETECT TUBING (PART NUMBER 0008-00-0312) AND THE BRACKET FRAME (0406-00-0626). IN AN UNRELATED REPAIR, THE BATTERY (0146-00-0039) WAS ALSO REPLACED. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. THE PARTS REPLACED ARE BEING REQUESTED TO BE SENT TO THE MANUFACTURING FACILITY AT (B)(4) FOR EVALUATION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    DURING A PREVENTIVE MAINTENANCE, THE COMPANY REPRESENTATIVE OBSERVED THAT THE BLOOD DETECTOR OF THE IABP COULD NOT BE CALIBRATED. HE ALSO OBSERVED THAT THE DOPPLER DOOR HINGE WAS BROKEN. NO PATIENT WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329900 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300

    Patients

    Seq Age Sex Outcome Treatment
    1