BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 16574111 · Received March 20, 2023

    Report

    Report Number
    2249723-2023-01547
    Event Type
    Malfunction
    Date Received
    March 20, 2023
    Date of Event
    March 9, 2023
    Report Date
    September 20, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE GETINGE SERVICE TERRITORY MANAGER (STM) THAT DISCOVERED THE SPILL REPLACED THE POWER MANAGEMENT BOARD. COMPLETED PM WITH FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECKS TO FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER FACTORY SPECIFICATIONS. THE UNIT WAS APPROVED FOR CLINICAL USE AND RETURNED TO THE DEPARTMENT. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED A POWER MANAGEMENT BOARD P/N 0670-00-1162, S/N (B)(6), WITH A REPORTED OF THE ¿SALINE SPILL ON UNIT, DAMAGED BOARD¿. PERFORMED VISUAL INSPECTION OF THE POWER MANAGEMENT BOARD PER THE CARDIOSAVE SERVICE MANUAL AND FOUND NO VISUAL DAMAGE AND THE PART LOOKS TO BE IN GOOD CONDITION. INSTALLED POWER MANAGEMENT BOARD INTO IABP CARDIOSAVE TEST FIXTURE FOR TESTING OF THE REPORTED PROBLEM. PERFORMED AND TESTED THE SYSTEM (45 MINUTES) IN ACCORDANCE WITH PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL IN AN ATTEMPT TO RECREATE THE REPORTED PROBLEM. FOUND THAT ALL FUNCTIONS WERE NORMAL. THE TESTS DID NOT TRIGGER THE REPORTED PROBLEM OF ¿SALINE SPILL ON UNIT, DAMAGED BOARD¿. THE FAILURE ANALYSIS AND TESTING DEPARTMENT WAS UNABLE TO REPLICATE THE FAILURE EXPERIENCED BY THE CUSTOMER. SENDING THE POWER MANAGEMENT BOARD TO THE SUPPLIER FOR FURTHER FAILURE ANALYSIS. THE PART ASSOCIATED TO THIS COMPLAINT WAS SUPPLIED TO US BY THE SUPPLIER (B)(4), AND IT IS A REVISION A POWER MANAGEMENT BOARD. OUR NEW SUPPLIER FOR THE POWER MANAGEMENT BOARD IS (B)(4), AND THEY ARE ONLY ABLE TO TEST 0670-00-1162 BOARDS THAT ARE REVISION G AND NEWER. THE PART NUMBER 0670-00-1162, POWER MANAGEMENT, ROHS SERIAL NUMBER (B)(6) RECEIVED FOR THIS COMPLAINT WILL NOT BE GOING BACK TO THE SUPPLIER. THE FAT DEPT WILL RETAIN THIS PART AS PER PROCEDURE.

    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) IT WAS DISCOVERED THAT SALINE HAD BEEN SPILLED ON THE UNIT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988122 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