BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300

    MDR report key: 11574574 · Received March 26, 2021

    Report

    Report Number
    2249723-2021-00634
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 4, 2021
    Report Date
    July 29, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 (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 DURING OFF-LABEL USE, WHILE WALKING THE PATIENT, A LOW BATTERY ALARM WAS ACTIVATED. THE END USER PLUGGED THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) INTO WALL POWER AND SWAPPED TO ANOTHER IABP UNIT. THE CUSTOMER REPORTED THAT THE BATTERIES WERE CHARGED OVERNIGHT AND RAN FOR 10 MINUTES. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A GETINGE SERVICE TERRITORY MANAGER (STM) WAS DISPATCHED TO INVESTIGATE AND REPORTED THAT BATTERIES LASTED ONLY 65 MIN. THE PROBLEM WAS SOLVED BY REPLACING THE BATTERIES 0146-00-0039 BATTERY, SEALED LEAD ACID,12V. THE STM THEN PERFORMED FULL FUNCTIONAL AND SAFETY TESTS. ALL TESTS PASSED PER MANUFACTURE SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER AND CLEARED FOR CLINICAL USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE WALKING THE PATIENT, A LOW BATTERY ALARM WAS ACTIVATED. THE CUSTOMER PLUGGED THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) INTO WALL POWER AND SWAPPED TO ANOTHER PUMP. THE CUSTOMER INFORMED THAT BATTERIES WERE CHARGED OVER NIGHT AND RAN 10 MINUTES. THERE WAS NO HARM OR INJURY TO THE PATIENT AND NO ADVERSE EVENT WAS REPORTED .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471945 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 ASKU (ASKED BUT UNKNOWN)