BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 98XT

    MDR report key: 23107177 · Received September 22, 2025

    Report

    Report Number
    2249723-2025-0003943
    Event Type
    Malfunction
    Date Received
    September 22, 2025
    Date of Event
    September 1, 2025
    Report Date
    September 26, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, E1 (EVENT SITE TELEPHONE), G3, G6, H2, H11. CORRECTED FIELDS: D4 (VERSION OR MODEL #).

    Additional Manufacturer Narrative · 0

    THIS DEVICE HAS BEEN UPGRADED FROM SYSTEM 98 TO CS300. BELOW ARE THE DETAILS OF CS300 (D1). BRAND NAME: CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V. CATALOG NO.: 0998-00-3023-53. UDI: (B)(4). 510(K) NO.: K063525. DUE TO CHARACTER LIMITATION EVENT SITE FULL NAME (E1): (B)(6). A GETINGE FIELD SERVICE ENGINEER (FSE) EXPLAINED THE FIRST PUMP WOULD NEED TO GO TO THEIR BIOMED. IN FUTURE IF WE RECEIVE ANY REPAIR INFORMATION WILL REOPEN AND UPDATE THE INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD SHOWED NO TRIGGER. THE PUMP ALARMED EVERY 5-10 SECONDS. ANOTHER PUMP HAS BEEN REPLACED AND WAS WORKING WITHOUT ISSUE. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2750599 SYSTEM 98XT SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0479-53

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male