BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 17415502 · Received July 28, 2023

    Report

    Report Number
    2249723-2023-03420
    Event Type
    Malfunction
    Date Received
    July 28, 2023
    Date of Event
    July 20, 2023
    Report Date
    July 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H4, H6, H10, H11. CORRECTED FIELDS: D1, D4. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT BUT WAS UNABLE TO DUPLICATE THE REPORTED MALFUNCTION. THE FSE REPLACED THE FIBER-OPTIC MODULE AS A PRECAUTION. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS ACCORDING TO FACTORY SPECIFICATIONS. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN: 0997-00-1169 SN: N/A FIBER OPTIC ASSEMBLY MODULE. PN: 0670-00-1160 SN: (B)(6) PART OF FIBER OPTIC ASSEMBLY MODULE. PN: 0992-00-1017 SN: (B)(6) PART OF FIBER OPTIC ASSEMBLY MODULE. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF FIBER OPTIC MODULE FAILED. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN CONDITION. INSTALLED THE FIBER OPTIC ASSY, INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. THE FAT DEPT. PERFORMED FIBER OPTIC TESTS AND FIBER OPTIC TEST PASSED WITHIN FACTORY SPECIFICATION CRITERIA. ALSO, THE FAT DEPT. PUMPED THE UNIT FOR 2 HOURS AND COULD NOT OBSERVE ANY FAILURE MESSAGE ON SCREEN. FIBER OPTIC ASSY, PASSED TESTING. SENDING PN: 0670-00-1160 SN: (B)(6) (PART OF FIBER OPTIC ASSEMBLY MODULE) TO THE RESPECTIVE SUPPLIER FOR ANALYSIS AS PER PROCEDURE. SENDING PN: 0992-00-1017 SN: (B)(6) (PART OF FIBER OPTIC ASSEMBLY MODULE) TO THE RESPECTIVE SUPPLIER FOR ANALYSIS AS PER PROCEDURE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED PART NUMBER 0670-00-1160 PCB, FOIM INTERFACE, ROHS SERIAL NUMBER (B)(6) FROM THE SUPPLIER. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. THE SUPPLIER TESTED THE BOARD AND NO ABNORMALITIES WERE DETECTED. THE BOARD PASSED TESTING. NO DEFECTS FOUND. THE FAILURE ANALYSIS AND TESTING DEPT. INSTALLED PART NUMBER 0670-00-1160 PCB, FOIM INTERFACE, ROHS SERIAL NUMBER (B)(6) INTO THE CARDIOSAVE TEST FIXTURE AND TESTED THE BOARD TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL. THE BOARD PASSED TESTING. RETAINING THE BOARD IN THE FAT PER PROCEDURE.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IABP TRAINING WITH THE ICU STAFF PERFORMED BY A GETINGE CLINICAL REP, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) ALARM SENSOR MODULE FAILURE APPEARED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1920061 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 N/A.