BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, 3.1 EDITION

    MDR report key: 19074166 · Received April 9, 2024

    Report

    Report Number
    2249723-2024-01476
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    April 1, 2024
    Report Date
    January 28, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567113432
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, D1, D4 (VERSION/MODEL#, CATALOG#), D9, G3, G6, H2, H3, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H10, H11 CORRECTED FIELDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE). ADDITIONAL INFORMATION: CONTACT PERSON DEPARTMENT: CLINICAL ENGINEER. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND SAFETY DISK LEAK TEST ERROR IS REOCCURRED, SAFETY DISK REPLACED. IN ADDITION TO LEAK TEST, ABOVE OPERATION CHECK WAS PERFORMED, EQUIPMENT IS IN GOOD CONDITION.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS PERFORMED BY A TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING (FAT) DEPARTMENT (B)(4), NJ: THE FAILURE ANALYSIS AND TESTING DEPARTMENT RECEIVED THE FOLLOWING PART ASSOCIATED WITH THIS COMPLAINT: SAFETY DISK. THIS PART WAS RECEIVED WITH A REPORTED UNIT FAILURE MESSAGE OF SAFETY DISK LEAK TEST ERROR. PERFORMED VISUAL INSPECTION OF THIS PART RECEIVED AND PART LOOKS TO BE IN GOOD CONDITION. INSTALLED SAFETY DISKS INTO THE CARDIOSAVE TEST FIXTURE AND TESTED TO THE FACTORY SPECIFICATIONS PER PROCEDURE AND THE CARDIOSAVE SERVICE MANUAL. THE FAILURE ANALYSIS AND TESTING DEPARTMENT COULD NOT VERIFY THE FAILURE MESSAGE OF SAFETY DISK LEAK TEST ERROR. SAFETY DISK PASSED TESTING WITHING FACTORY SPECIFICATION. RETAINING SAFETY DISK IN THE FAT DEPT. PER PROCEDURE. THE ROOT CAUSE FOR THIS FAILURE IS NOT CONFIRMED AS FAT WERE NOT ABLE TO REPRODUCE THE ERROR.

    Additional Manufacturer Narrative · 0

    **UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

    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 BEFORE USE, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SAFETY DISK LEAK TEST ERROR. THE UNIT IS NOT IN CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SAFETY DISK LEAK TEST ERROR. THE UNIT IS NOT IN CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512866 CARDIOSAVE HYBRID, 3.1 EDITION SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-65 10607567113432

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown