BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID INT TYPE B PLUG

    MDR report key: 14192798 · Received April 25, 2022

    Report

    Report Number
    2249723-2022-00922
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 25, 2022
    Report Date
    September 5, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP. TO FIX THE ISSUE, THE FSE REPLACED THE FIBER OPTIC ASSEMBLY, AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED TO THE CUSTOMER AND CLEARED FOR CLINICAL SERVICE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE FIBER OPTIC MODULE 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 AND THE CARDIOSAVE SERVICE MANUAL. NO PROBLEM WAS FOUND. THE FIBER OPTIC MODULE BOARD WILL BE SENT TO THE RESPECTED SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE NUMBER 0002-07-D008 REVISION AJ. THE FAT DEPT RECEIVED FIBER OPTIC MODULE FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: PERFORM VISUAL CHECK AND NO ABNORMALITIES FOUND. BOARD WAS RE-TESTED AT FCT AND PASSED TESTING. RESULTS AT INSPECTION AND TEST IS GOOD AND NO ABNORMALITIES WAS DETECTED. BOARD WAS NDF" THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE 0002-07-D008. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING INSPECTION, BEFORE DELIVERY, THE CARDIOSAVE INTRA- AORTIC BALLOON PUMP (IABP) BECAME OUT OF STANDARD OF THE FIBER TEST FOR THE LAMP OUTPUT. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184209 CARDIOSAVE HYBRID INT TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-65 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown