BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17450264 · Received August 3, 2023

    Report

    Report Number
    2249723-2023-03508
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 25, 2023
    Report Date
    April 26, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ADDITIONAL CUSTOMER COTACT INFORMATION: NAME: (B)(6), OCCUPATION: BIOMEDICAL ENGINEER A GETINGE FIELD SERVICE ENGINEER (FSE) REPLACED TOP COVER, THIS CORRECTED ISSUE. DEVICE PASSED SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO CUSTOMER AND CLEARED FOR CUSTOMER USE. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE FOLLOWING WAS PERFORMED BY (B)(6), TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING WAYNE, NJ (B)(6). THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: TOP COVER THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF DAMAGED TOP COVER. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND OBSERVED TOP COVER HAS CRACK ON IT. PLEASE SEE ATTACHED PICTURE. RETAINING TOP COVER IN THE FAT DEPT., AS PER PROCEDURE (B)(4). THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS IMPOSSIBLE TO BE DEFINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PREVENTATIVE MAINTENANCE PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (GFSE), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT'S TOP DISPLAY WAS FOUND DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1658233 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 Unknown N/A.