BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 6712527 · Received July 13, 2017

    Report

    Report Number
    2249723-2017-00091
    Event Type
    Malfunction
    Date Received
    July 13, 2017
    Date of Event
    June 21, 2017
    Report Date
    July 13, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IN REGARDS TO THE PREVIOUSLY SUBMITTED NARRATIVE PM STANDS FOR PREVENTATIVE MAINTENANCE, AND HE STANDS FOR HELIUM. (B)(6). THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. A FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE HE TRANSDUCER OFFSET WAS HIGHER THAN THE CUSTOMER HAD USUALLY SEEN, BUT IT WAS WITHIN SPECIFICATION. THE FSE CALIBRATED THE HE TRANSDUCER TO LOWER THE OFFSET. A COMPLETE PM WITH FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECKS TO FACTORY SPECIFICATIONS WAS PERFORMED. THERE WERE NO PARTS REPLACED. THE IABP WAS RETURNED FOR CLINICAL USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SERVICE TEST THE INTERNAL TRANSDUCERS WOULD NOT CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT, THEREFORE NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490455 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1