BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 11864033 · Received May 21, 2021

    Report

    Report Number
    2249723-2021-01075
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 29, 2021
    Report Date
    August 2, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    HISTORICAL DATA ANALYSIS: (4109/131) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME SERIAL NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/131) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD ((B)(6) 2019 THROUGH (B)(6) 2021) WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD. ANALYSIS OF PRODUCTION: (3331/131) THE DEVICE HISTORY RECORDS REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED SERIAL NUMBER. BASED ON THE DHR/LHR REVIEW RESULTS, IT WAS DETERMINED THAT THERE IS NO RELATION BETWEEN THE MANUFACTURING PROCESS AND THE REPORTED FAILURE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    THE GETINGE SERVICE TERRITORY MANAGER (STM) THAT ENCOUNTERED THE ISSUE, REPORTED THAT BATTERIES ONLY PROVIDED POWER TO THE DEVICE FOR 92 MINUTES. THE STM REPLACED BATTERIES AND COMPLETE PM WITH FULL CALIBRATION. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FAILED BATTERY SHORT RUN TIME TEST. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760443 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-53 N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A.