BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 21736764 · Received April 1, 2025

    Report

    Report Number
    2249723-2025-0001513
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 18, 2025
    Report Date
    August 1, 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

    DUE TO CHARACTER LIMITATION IN E1 FULL EVENT SITE NAME IS (B)(6). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, E1(EMAIL), G1, G3, G6, H2, H6 ( TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION), H11. CORRECTED FIELDS - H6(MEDICAL DEVICE ¿ PROBLEM CODE). A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, RAN UNIT THROUGH A FIBER OPTIC TEST WITH THE FIBER OPTIC TEST UNIT, AND IT FAILED WITH A MESSAGE OF FIBER OPTIC ERRORS, AND THERE WERE NO DATA NUMBERS, DISASSEMBLE THE UNIT CHECKED ALL THE CONNECTIONS DOWN TO THE FIBER OPTIC MODULE ALL LOOKED GOOD REMOVED THE ORIGINAL FIBER OPTIC MODULE AND INSTALLED A NEW FIBER OPTIC ASSEMBLY (0997-00-1169) AND RECHECKED AND ALL WORKS AS IT SHOULD NOW. RAN UNIT THROUGH MULTIPLE FIBER OPTIC TEST AND ALL PASSED AND MEETS FACTORY SPECIFICATIONS, RAN UNIT THROUGH A FULL FUNCTIONALITY AND ELECTRICAL SAFETY TEST AND RANON TEST, BALLOON AND ALL MEET FACTORY SPECIFICATIONS, UNIT WAS RETURNED TO CUSTOMER FOR USE. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-USE CHECKOUT CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAD FIBER OPTIC ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055581 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