BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 220V

    MDR report key: 21618122 · Received March 17, 2025

    Report

    Report Number
    2249723-2025-0001249
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    February 27, 2025
    Report Date
    October 22, 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, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H11. CORRECTED FIELDS: H6 (MEDICAL DEVICE ¿ PROBLEM CODE, INVESTIGATION FINDINGS).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G1 (CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H11. CORRECTED FIELDS: E1 (EVENT SITE TELEPHONE), H6 (HEALTH EFFECT ¿ IMPACT CODES).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G3, G6, H11. CORRECTED FIELDS:H6 (MEDICAL DEVICE ¿ PROBLEM CODE).

    Additional Manufacturer Narrative · 0

    UPDATED DATA: B4, G3, G6, H1, H2, H11 CORRECTED DATA: H6 (COMPONENT CODES, MEDICAL DEVICE ¿ PROBLEM CODE).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, B5, B6, B7, E1, E2, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSION), H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND POWER SUPPLY ASSEMBLY WAS DEFECTIVE. FSE STATED NO REPAIR IS YET CARRIED OUT AND NO RESPONSE YET RECEIVED ON CONTRACT RENEWAL FROM THE CUSTOMER. AS OF NOW, THE INVESTIGATION IS CLOSED, IF ANY NEW INFORMATION IS RECEIVED FUTURE RELATED TO PART REPLACEMENT WILL REOPEN THE COMPLAINT AND UPDATE IT.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS - B4, G3, G6, H2, H11. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED THE UNIT AND FOUND POWER SUPPLY ASSEMBLY WAS DEFECTIVE. FSE STATED CUSTOMER WONT BE GOING FOR CONTRACT RENEWAL OR PURCHASE OF THE SPARE INSTEAD THEY HAVE BOUGHT 3 NEW MACHINES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY STATUS IS EMPTY. NO ONE WAS HARMED ONSITE.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING ROUTINE CHECK THAT CS100 INTRA-AORTIC BALLOON PUMP (IABP) BATTERY STATUS IS EMPTY. THERE WAS NO PATIENT INVOLVED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209965 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 N/A.| UNKNOWN.