BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 21353987 · Received February 11, 2025

    Report

    Report Number
    2249723-2025-0000645
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Date of Event
    January 22, 2025
    Report Date
    June 12, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107295
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D9, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION , INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H11 CORRECTED FEILDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE). A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND WAS ABLE TO REPRODUCE THE REPORTED MALFUNCTION. AFTER CROSS-CHECKING A VARIETY OF PARTS, THE FSE REPLACED THE DSS DATASETTE ASSEMBLY (0670-00-1185) AND THE IAB DATASETTE ASSEMBLY (0670-00-1184). THE UNIT WAS OBSERVED FOR OVER FOUR HOURS AND WAS FOUND TO BE WORKING OKAY. OBSERVATION WAS CONTINUED FOR THE NEXT FIVE DAYS. THE UNIT WAS HANDED OVER TO THE CUSTOMER IN GOOD, WORKING CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING ROUTINE CHECK, CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT WAS INDICATING SYSTEM FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610173 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-55 10607567107295

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown