BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE I PLUG

    MDR report key: 15339152 · Received September 1, 2022

    Report

    Report Number
    2249723-2022-02239
    Event Type
    Malfunction
    Date Received
    September 1, 2022
    Date of Event
    August 23, 2022
    Report Date
    September 19, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108421
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS TELEPHONE NUMBER : (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND THAT AFTER THE IABP WAS TURNED ON, THE ELECTRICAL SAFETY TEST FAILED AND THE FIBER OPTIC FAILURE WAS DISPLAYED. THE FSE REPLACED THE FIBER OPTIC MODULE. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. THE FIBER OPTIC MODULE PART NUMBER 0997-00-1169 WAS OBSERVED PER THE CARDIOSAVE SERVICE MANUAL WITH NO VISUAL DAMAGE. THE NATIONAL REPAIR CENTER INSTALLED THE FIBER OPTIC MODULE INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE FIBER OPTIC MODULE TO FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE PROBLEM WAS OBSERVED AND VERIFIED. (FIBER OPTIC MODULE FAILURE - ERROR CODE 6 AND 53) THE FIBER OPTIC MODULE BOARDS P/N 0670-00-1160 AND 0992-00-1017 WILL BE SENT TO THE RESPECTED SUPPLIERS FOR FAILURE ANALYSIS PER PROCEDURE. THE FAT DEPT RECEIVED PART NUMBER: 0670-00-1160 SERIAL NUMBER:(B)(6) FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM INCOMING VISUAL INSPECTION RESULT: FOUND CONNECTOR AT J2 LOCATION WAS BROKEN. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT FAILS ELECTRICAL SAFETY TEST FAILS, INDICATING THAT THE OPTICAL FIBER IS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2823609 CARDIOSAVE HYBRID, TYPE I PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-45 10607567108421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown