BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 11329949 · Received February 15, 2021

    Report

    Report Number
    2249723-2021-00280
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Date of Event
    January 21, 2021
    Report Date
    October 12, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567107882
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECTED FAULTY BATTERIES HAVE NOT BEEN REQUESTED TO BE RETURNED FOR FURTHER EVALUATION DUE TO SHIPPING RESTRICTIONS. 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 12 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD (FEB 2020 THROUGH JAN 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 AN UNBOXING OF A NEW CS300 INTRA-AORTIC BALLOON PUMP (IABP) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), THE BATTERY COULD NOT BE CHARGED. THIS IS A FAILURE UPON INSTALLATION OF THE BATTERIES. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Additional Manufacturer Narrative · 1

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THIS UNIT. THE FSE CONFIRMED THE ISSUE AND REPLACED THE BATTERIES. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY WOULD NOT CHARGE OUT-OF-BOX. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223717 CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-3023-55 NA 10607567107882

    Patients

    Seq Age Sex Outcome Treatment
    1