BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CS300

    MDR report key: 3872053 · Received April 17, 2014

    Report

    Report Number
    2249723-2014-00466
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TECHNICIAN NOTED "MAINTENANCE REQUIRED CODE #2" MESSAGES AND "CODE 58 (BIMBA FILL FAULT)" IN ERROR LOGS. HE OBSERVED K6 VALVE STICKING. HE REPLACE MANIFOLD DRIVE ASSEMBLY (PART NUMBER: 0104-00-0018). PERFORMED COMPLETE PM, CLEANING AND CALIBRATION TO SPECIFICATIONS AND RAN FUNCTION & SAFETY TEST. THE IABP WAS RETURNED TO THE CUSTOMER. INTERNAL FILE: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP DISPLAYED MAINTENANCE CODE #2 (DRIVE TRANSDUCER OFFSET FAILURE). THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235553 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CS300

    Patients

    Seq Age Sex Outcome Treatment
    1 Other