BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V

    MDR report key: 22456327 · Received July 9, 2025

    Report

    Report Number
    2249723-2025-0002931
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Date of Event
    June 24, 2025
    Report Date
    August 18, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107486
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, B6, B7, D9 (DEVICE AVAILABLE FOR EVAL), D10, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, HEALTH EFFECT - IMPACT CODES, INVESTIGATION CONCLUSIONS), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE IABP UNIT AND WAS ABLE TO REPRODUCE THE REPORTED ISSUE. TO FIX THE ISSUE, THE FSE CLEANED THE VIDEO CARD CONTACTS AND REPLACED THE COILED CABLE AND PERFORMED ALL FUNCTIONAL AND SAFETY CHECKS TO MEET FACTORY SPECIFICATIONS. UNIT PASSED ALL FUNCTIONAL AND SAFETY TEST PER FACTORY SPECIFICATIONS. THE IABP WAS THEN RELEASED AND CLEARED FOR CLINICAL SERVICE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: KINDLY DISREGARD THE PREVIOUS MDR (2249723-2025-0002931) FOLLOW UP 1 AS IT WAS SUBMITTED IN ERROR. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION AND ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, B6, B7, D9, D10, E2, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSION, IMPACT CODES), H11. A GETINGE FIELD SERVICE ENGINEER CHECKED THE MACHINE, DEFECT WAS ELIMINATED BY CLEANING THE VIDEO CARD CONTACTS AND REPLACING THE MONITOR'S SPIRAL CABLE. OPERATIONAL TESTS PERFORMED SUCCESSFULLY. REPAIR COMPLETED, THE EQUIPMENT CAN BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS VIBRATING AND WAS UNREADABLE. NO HARM/ ADVERSE EVENT WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, THE CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS VIBRATING AND WAS UNREADABLE. HOWEVER, THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE, CS100 INTRA-AORTIC BALLOON PUMP (IABP) DISPLAY WAS VIBRATING AND WAS UNREADABLE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117446 CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-3013-67 10607567107486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNKNOWN.