BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19804240 · Received July 23, 2024

    Report

    Report Number
    2249723-2024-02937
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 2, 2024
    Report Date
    May 27, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4; D8; D9; E1 INITIAL REPORTER; G3; G6; H2; H3; H6 TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION; COMPONENT CODE; H11 A GETINGE FIELD SERVICE ENGINEER (FSE) CHECKED THE DEVICE AND CONFIRMED THE FAULT CODES 111 AND 118 THAT HAD OCCURRED. AS PER THE SERVICE MANUAL, FSE REPLACED THE EXECUTIVE PROCESSOR BOARD (D670-00-0770), REDOWNLOADED THE B17SOFTWARE AND RECALIBRATED THE SYSTEM. RAN UNIT ON A TRAINER AND TEST BALLOON FOR APPROX 1 HOUR WITH NO ISSUES, RAN UNIT THROUGH A FULL CALIBRATION AND ELECTRICAL SAFETY TESTS ALL MEETS FACTORY SPECIFICATIONS, UNIT WAS RETURNED TO THE CUSTOMER. THE FOLLOWING WAS PERFORMED BY (B)(4). FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT (B)(4): SR (B)(6) OCT 2024. THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: PN: 0670-00-0770 REV K, SN: (B)(6) EXEC. PROCESSOR BOARD. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF AFTER UNIT TURNED ON, ALARM OCCURRED AND FOUND CODE 111, 118. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED EXEC. PROCESSOR BOARD INTO THE CARDIOSAVE TEST FIXTURE SN (B)(4) AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION E AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION R. PERFORMED ALL FUNCTIONAL TESTS AND PASSED. AFTER UNIT WAS TURNED ON AND RAN UNIT FOR APPROX 1 HOUR AND DID NOT OBSERVE ALARM SOUND. UNIT WORKED CORRECTLY. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF ALARM AND CODE 111, 118. EXEC. PROCESSOR BOARD PASSED TESTING. RETAINING EXEC. PROCESSOR BOARD IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AR. DUE TO OLD REVISION, THIS BOARD IS NOT GOING TO SUPPLIER FOR FURTHER INVESTIGATION. 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

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS TURNED ON FOR A MAINTENANCE CHECK AND THE UNIT HAD A STEADY ALARM,. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934780 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.