BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98XT, ENGLISH, 110V

    MDR report key: 24245339 · Received February 3, 2026

    Report

    Report Number
    2249723-2026-0001070
    Event Type
    Malfunction
    Date Received
    February 3, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 3, 2026
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K961509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTERIZATION LIMIT E1 EVENT SITE NAME: (B)(6). UNIQUE IDENTIFIER (UDI) #: KEPT AS BLANK AS NO DETAILS AVAILABLE. SYS98 UPGRADED TO CS300 INTRA AORTIC BALLOON PUMP. THE UPGRADED DEVICE DETAILS ARE BELOW: BRAND NAME: CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V, CATALOG NUMBER: 0998-00-3023-68. UDI NUMBER: (B)(4). 510K: K063525. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA AORTIC BALLOON PUMP (IABP) HAD FAULT CODE 50, SAYS ELECTRICAL FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305262 SYSTEM 98XT, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0479-53

    Patients

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