BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 13478927 · Received February 8, 2022

    Report

    Report Number
    2249723-2022-00237
    Event Type
    Malfunction
    Date Received
    February 8, 2022
    Date of Event
    January 17, 2022
    Report Date
    September 9, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A PREVENTATIVE MAINTENANCE (PM) SERVICE, THE GETINGE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS NOT DISPLAYING THE FIBER OPTIC WAVEFORM. TO FIX THE ISSUE, THE FSE REPLACED THE ASSY,FIBER OPTIC,ROHS, ASSEMBLY, TETHER AND THEN PERFORMED FUNCTIONAL AND SAFETY CHECKS TO MEET 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. (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9(RETURN TO MANUFACTURE DATE), G3, G6, G7, H2, H4, H6(INVESTIGATION TYPE, INVESTIGATION FINDINGS & INVESTIGATION CONCLUSIONS), H10, H11. CORRECTED FIELDS: D4(UDI#), H6(COMPONENT CODES). THE FIBER OPTIC MODULE PART NUMBER 0997-00-1169 WAS RECEIVED BY MAQUET NATIONAL REPAIR CENTER (NRC). THE PART 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 NRC VERIFIED THE INTERMITTENT FAILURE OF THE FIBER OPTIC MODULE ASSEMBLY ( NO WAVEFORMS OBSERVED DURING FIBER OPTIC TESTING). THE FIBER OPTIC MODULE BOARD WAS SENT TO THE SUPPLIER FOR FAILURE ANALYSIS PER PROCEDURE. THE MAQUET FAILURE AND TESTIGN DEPARTMENT (FAT) DEPT RECEIVED PART NUMBER: 0670-00-1160 FROM THE SUPPLIER. THE SUPPLIER EVALUATION STATES THE FOLLOWING: 1. PERFORM VISUAL CHECK. RESULT: NO ABNORMALITIES FOUND. 2. BOARD WAS RE-TESTED AT FCT . RESULT: PASSED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM), THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WOULD NOT DISPLAY FIBER OPTIC WAVEFORM DURING A SYSTEM TEST. THERE WAS NO PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301706 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown