BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 11379829 · Received February 25, 2021

    Report

    Report Number
    2249723-2021-00412
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    February 5, 2021
    Report Date
    August 4, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6 (INVESTIGATION FINDINGS, COMPONENT CODES, HEALTH EFFECT - IMPACT CODES, INVESTIGATION CONCLUSIONS), H10. THE GETINGE FIELD SERVICE ENGINEER (FSE) HAS ADVISED THAT THE CUSTOMER HAS NOT APPROVED THE REPLACEMENT OF THE BATTERIES. IT WAS NOTED THAT THE CUSTOMER IS CURRENTLY USING THE IABP UNIT ON MAINS POWER ONLY AND NOT ON THE BATTERIES. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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 (MAR-2019 THROUGH FEB-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

    IT WAS REPORTED THAT WHILE SERVICING A UNIT, THE GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BACKUP BATTERY WAS LOW. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO INVESTIGATE. THE FSE EVALUATED THE UNIT AND FOUND THAT THE BACK UP BATTERY WAS TOO LOW. THE FSE DETERMINED THAT THE BATTERIES NEEDED REPLACEMENT. THE FSE SUBMITTED AN ESTIMATE TO THE CUSTOMER AND AWAITS APPROVAL. NOTWITHSTANDING, THE FSE PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS WERE PERFORMED. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. AT THIS TIME, ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE REPAIR AND STATUS OF THE IABP UNIT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THIS INFORMATION IS PROVIDED TO US. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SERVICING A UNIT, THE GETINGE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BACKUP BATTERY WAS LOW. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274563 CS300 SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-55 N/A 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1