BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM

    MDR report key: 21907536 · Received April 25, 2025

    Report

    Report Number
    2249723-2025-0001947
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 13, 2025
    Report Date
    July 2, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567107745
    PMA / PMN Number
    K031636
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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: CORRECTED FIELDS: D1, D4 (MODEL, CATALOG, UDI), E2.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D4 (UDI), G3, G6, H2, H3, H6 (INVESTIGATION FINDINGS , INVESTIGATION CONCLUSION, TYPE OF INVESTIGATION), H11 CORRECTED FIELDS: B5, D1 (BRAND NAME), G3 CORRECT DATE RECEIVED BY MFG DATE IN FOLLOW UP 1 EMDR (2249723-2025-0001947 ) WAS (B)(6) 2025, G4 HOWEVER THIS IABP WAS UPGRADED TO A CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V CATALOG #0998-00-3023-53 UDI # (B)(4), WHICH WAS REPORTED BY THE CUSTOMER A GETINGE FIELD SERVICE ENGINEER (FSE) COULD NOT DUPLICATE THE REPORTED ISSUE AS THE DEVICE SERVICED BY THE CUSTOMER. ALL FUNCTIONAL AND SAFETY CHECKS ARE MEET TO FACTORY SPECIFICATIONS PERFORMED AND RETURNED TO USE.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B3, B4, D4 (SERIAL NO.), D8, D9, E1 (EVENT SITE TELEPHONE), G3, G6, H2, H11. CORRECTED FIELDS: D4 (VERSION, CATALOUGE). A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) RECEIVED A "DISCONNECTED" ERROR ON A CS300 BUT STATES THAT "ALL WIRES AND TUBES WERE CONNECTED." FURTHER REPORTED THAT PATIENT WAS NOT MOVING AND HELIUM TANK LEVEL WAS ACCEPTABLE AND CS300 GOES INTO STANDBY AUTOMATICALLY DURING "IAB DISCONNECTED" ALARM. THERE WAS NO HARM REPORTED TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CS300 INTRA-AORTIC BALLOON PUMP (IABP) RECEIVED A "DISCONNECTED" ERROR ON A CS300 BUT STATES THAT "ALL WIRES AND TUBES WERE CONNECTED." FURTHER REPORTED THAT PATIENT WAS NOT MOVING AND HELIUM TANK LEVEL WAS ACCEPTABLE AND CS300 GOES INTO STANDBY AUTOMATICALLY DURING "IAB DISCONNECTED" ALARM. THERE WAS NO HARM REPORTED TO PATIENT. HOWEVER THIS IABP WAS UPGRADED TO A CS300 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V CATALOG # 998-00-3013-53 UDI #(B)(4), WHICH WAS REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192446 CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-UC-3013-53 10607567107745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown