BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 12242547 · Received July 28, 2021

    Report

    Report Number
    2249723-2021-01637
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    July 6, 2021
    Report Date
    September 10, 2021
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF PRODUCTION: (3331/213) THE DEVICE HISTORY RECORD REVIEW CONCLUDED THAT THERE WERE NO NCMRS, REWORK, OR DEVIATIONS DOCUMENTED FOR THE REPORTED LOT/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. HISTORICAL DATA ANALYSIS: (4109/213) THE REVIEW OF THE HISTORICAL DATA INDICATES THAT NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE SAME LOT/SERIAL NUMBER AND REPORTED FAILURE MODE. TREND ANALYSIS: (4110/213) THE OVERALL 24 MONTH PRODUCT COMPLAINT TREND DATA FOR THE PERIOD AUG 2019 THROUGH JUL 2021 WAS REVIEWED. THERE WERE NO TRIGGERS IDENTIFIED FOR THE REVIEW PERIOD.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

    DEVICE NOT ACCESSIBLE FOR TESTING: THE CUSTOMER CANCELLED SERVICE FOR GETINGE TO EVALUATE THE IABP UNIT INVOLVED IN THIS EVENT. A GETINGE FIELD SERVICE ENGINEER (FSE) CONVERSED WITH THE CUSTOMER BIOMEDICAL ENGINEER AND WAS ADVISED THAT THERE WAS NO ISSUE WITH THE IABP UNIT, BUT RATHER THAT THERE WAS AN ISSUE WITH THE IP ADDRESS SETTING IN THE HICS SYSTEM ON THE CUSTOMER'S END. ADDITIONALLY, THE CUSTOMER ADVISED THAT AFTER THE UNIT WAS BROUGHT DOWN TO THE SHOP, THE UNIT WORKED FINE WITH THE COMMUNICATIONS. THE CUSTOMER FOUND THAT THE END USERS HAD THE UNIT PLUGGED INTO THE WRONG NETWORK PORT WHICH CAUSED THE COMMUNICATION ISSUE. THE IABP UNIT WAS RETURNED TO SERVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD A COMMUNICATION ISSUE WITH THE BOARD. NO PATIENT HARM, SERIOUS INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1136189 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN.