BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 21166485 · Received January 16, 2025

    Report

    Report Number
    2249723-2025-0000232
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 30, 2024
    Report Date
    February 28, 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

    UPDATED: B4, G1, G3, G6, H2, H4, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS) AND H11. A GETINGE FIELD SERVICE ENGINEER (FSE) ON DT: 30.12.2024- CHECKED AND FOUND THAT BELOW MENTIONED PART IS DEFECTIVE AND NEEDS REPLACEMENT AS SOON AS POSSIBLE. P/N: D102-00-0001, HYDR CMPNT PUMP ASSY DC KNF. UNIT HANDED OVER TO THE CUSTOMER IN THE SAME NOT WORKING CONDITION. ON DT: 02.01.2025- REPLACED THE DEFECTIVE COMPLETE COMPRESSOR/MOTOR ASSLY INCLUDING NEW 5000 HOURS PREVENTIVE MAINTENANCE KIT WITH A NEW ONE UNDER CMC. NOW THE ABOVE PROBLEM HAS BEEN RECTIFIED AND COMPLETELY RESOLVED AND NO ERROR MESSAGES ON THE DISPLAY. UNIT IS WORKING SATISFACTORILY. UNIT IS HANDED OVER TO THE CUSTOMER IN WORKING CONDITION.

    Additional Manufacturer Narrative · 0

    DUE TO CHARACTER RESTRICTIONS IN BLOCK E1 , E1 EVENT SITE FULL NAME IS (B)(6) HOSPITALS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) UNIT EXPERIENCED A LOW VACUUM FAILURE ISSUE. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1251729 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