BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 18313141 · Received December 12, 2023

    Report

    Report Number
    2249723-2023-05269
    Event Type
    Malfunction
    Date Received
    December 12, 2023
    Date of Event
    November 29, 2023
    Report Date
    September 1, 2024
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT FOR THE REPORTED MALFUNCTION. THE FSE DISASSEMBLED THE CARDIOSAVE AND REPLACED THE FIBER-OPTIC CONNECTOR (0012-00-1562). THE FSE TESTED THE FIBER-OPTIC CIRCUIT WITH A TESTER. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS TO FACTORY SPECIFICATIONS. THE IABP WAS RETURNED TO THE CUSTOMER. THE FOLLOWING INVESTIGATION WAS PERFORMED BY THE FAILURE ANALYSIS AND TESTING DEPT. (FAT) THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0012-00-1562 REV. E, WITH A REPORTED UNIT FAILURE OF THE FIBER OPTIC CONNECTOR BEING BROKEN. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE BROKEN AT THE CONNECTION PORT. FAT WAS ABLE TO VERIFY THE REPORTED ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ROUTINE CHECK ,THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS OBSERVED BY THE CUSTOMER HAVING A DAMAGED FIBER OPTIC CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303697 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown