BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 22217280 · Received June 17, 2025

    Report

    Report Number
    2249723-2025-0002621
    Event Type
    Malfunction
    Date Received
    June 17, 2025
    Date of Event
    June 3, 2025
    Report Date
    August 6, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, B5, B6, B7, D10, E1(INITIAL REPORTER), G1, G3, G6, H2, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE STATES, THE BLUE FIBER OPTIC CONNECTOR WAS NOT INSTALLED PROPERLY. FSE TOOK IT OFF AND INSTALLED IT CORRECTLY. THE UNIT THEN PASSED THE FIBER OPTIC TESTING AND A SYSTEM CHECKOUT AND WAS CLEARED FOR CLINICAL USE. COMPLETED REPAIR SUCCESSFULLY. PRODUCT PASSED ALL FUNCTIONAL AND SAFETY TESTS PER MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS GETTING A FIBER OPTIC ERROR CODE. THERE WAS NO HARM REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT IS GETTING A FIBER OPTIC ERROR CODE, PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594540 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