BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16654683 · Received March 31, 2023

    Report

    Report Number
    2249723-2023-01706
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 21, 2023
    Report Date
    June 19, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H2, H6, H10, H11. CORRECTED FIELDS: H6 (TYPE OF INVESTIGATION). IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FACING "DOPPLER RELATED MALFUNCTION" ISSUE. A GETINGE FIELD SERVICE ENGINEER (FSE) DISCOVERED AS PART OF THE PM, DOPPLER TRAYS HINGES ARE BROKEN. THE FSE REPLACED THE CHASSIS STORAGE BINS (D441-00-0196). UNIT FULLY FUNCTIONAL, RETURNED TO CLINICAL USE . THE IABP UNIT WAS CLEARED FOR CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AS PART OF THE PM THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) FACING "COMPONENT BROKEN" ISSUE. A GETINGE FIELD SERVICE ENGINEER (FSE) DISCOVERED AS PART OF THE PM, DOPPLER TRAY HINGES BROKEN. THE FSE REPLACED THE CHASSIS STORAGE BINS (D441-00-0196). UNIT FULLY FUNCTIONAL, RETURNED TO CLINICAL USE . THE IABP UNIT WAS CLEARED FOR CLINICAL USE. NO PATIENT INVOLVEMENT WAS THERE. ADDITIONAL POINT OF CONTACT: NAME: (B)(6). E-MAIL ADDRESS: (B)(6). PHONE NUMBER: (B)(6). DEPARTMENT: BIOMED. OCCUPATION: BIOMEDICAL ENGINEER.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNITS DOPPLER TRAYS HINGES ARE BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059626 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose