BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    MDR report key: 21419173 · Received February 20, 2025

    Report

    Report Number
    2249723-2025-0000778
    Event Type
    Malfunction
    Date Received
    February 20, 2025
    Date of Event
    February 3, 2025
    Report Date
    October 13, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107394
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE AND REPLACED BATTERIES (D146-00-0039) BECAUSE THEY DIDN'T LAST FOR THE PM. REPLACED POWER CORD (D012-00-0886-01) DUE TO NORMAL WEAR AND TEAR. UNIT PASSED ALL CALIBRATION, FUNCTIONAL AND SAFETY TESTS PERFORMED. UNIT WAS RETURNED TO CUSTOMER AND CLEARED FOR CLINICAL USE.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H11 CORRECTED FIELD: H6 (INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS).

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BATTERIES OF CS100 INTRA-AORTIC BALLOON PUMP (IABP) DIDN¿T LAST FOR THE PM. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209038 CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-53 10607567107394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown