BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19643641 · Received July 1, 2024

    Report

    Report Number
    2249723-2024-02646
    Event Type
    Malfunction
    Date Received
    July 1, 2024
    Report Date
    October 23, 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

    CORRECTED FIELDS: D4. THE GETINGE FIELD SERVICE ENGINEER WAS UNABLE TO REPLICATE CODE 137. AS A PRECAUTION, THE FSE REPLACED THE VIDEO GENERATOR BOARD. ALSO, THE FSE FOUND THAT FIBER OPTIC CONNECTOR WAS LOOSE, SO THE FIBER UPPER PANEL ASSEMBLY WAS REPLACED. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER: 0012-00-1787 SERIAL NUMBER:(B)(6), PART NUMBER: 0670-00-1169_A UPPER DISPLAY MONITOR BOARD SERIAL NUMBER: (B)(6) AND PART NUMBER: 0670-00-781_J VIDEO GENERATOR SERIAL NUMBER: (B)(6) AND PART NUMBER: 0997-00-0644 SERIAL NUMBER: N/A WITH A REPORTED UNIT FAILURE OF MULTIPLE CODE 137IN FAULT JOURNAL AND BROKEN FIBER OPTIC DOOR. THE FAT DEPT. PERFORMED A VISUAL INSPECTION OF ALL PARTS RECEIVED AND FOUND THAT P/N: 0670-00-1169 AND 0670-00-781 ARE IN GOOD CONDITION, BUT PART NUMBER: 0997-00-0644 HAS A BROKEN FIBER OPTIC DOOR. DUE TO THE BROKEN FIBER OPTIC DOOR, PART NUMBER: 0997-00-0644 CANNOT BE INSTALLED AND INVESTIGATED ANY FURTHER. THE FAT DEPT. INSTALLED 0012-00-1787 CABLE SERIAL NUMBER:(B)(6) PART NUMBER: 0670-00-1169_A SERIAL NUMBER: (B)(6) AND PART NUMBER: 0670-00-781_J VIDEO GENERATOR SERIAL NUMBER: (B)(6) IN THE CARDIOSAVE TEST FIXTURE AND TESTED JOINTLY AND SEPARATELY IN ACCORDANCE WITH FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT REPLICATE TO FAILURE EXPERIENCED BY THE CUSTOMER. RETAINING THE BOARDS (BOARDS REVISIONS ARE OBSOLETE AND NO LONGER ABLE TO BE TESTED BY A SUPPLIER) IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER. RETAINING PART NUMBER: 0997-00-0644 AND PART NUMBER: 0012-00-1787 IN THE FAT DEPT. PER PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    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) DISPLAYED CODE 137. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566108 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