MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-83
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs300 intra-aortic balloon pump (iabp) screen was flickering and it had flashing lines on it.No harm to the patient.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: h6 (health effect impact codes).
Event or Problem Description
N/a.
Event or Problem Description
It was reported that during a routine check, the cs300 intra-aortic balloon pump (iabp) exhibited screen flickering, with flashing lines visible on the display.No patient was involved or harm was reported.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d9, d10, e1 (initial reporter, event site telephone, event site email), g3, g6, h2, h3, h6 (type of investigation, investigation findings and investigation conclusions), h11.A getinge field service engineer fse inspected the unit and replaced the pcb inverter dc to ac d671-00-0230.The unit passed all functional and safety tests in accordance with the manufacturer's specifications.The following investigation was performed by the technician of the maquet failure analysis and testing dept.Fat wayne nj.The failure analysis and testing dept.Received part number 0670-00-0230 inverter board dc to ac serial number (b)(6) with a reported unit failure of the screen is flickering, it has flashing lines on it.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed part number 0670-00-0230 inverter board dc to ac serial number (b)(6) into the cs300 test fixture serial number (b)(6) and tested the board to factory specifications per the cs300 service manual part number 0070-00-0689 rev.W.The fat dept.Booted the cs300 into clinical mode.The cs300 pumped for two hours, no screen flickering was observed, and no flashing lines on the display.The board passed testing.Retaining the board in the fat dept.Per procedure number 0002-07-d008 rev.Au.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,UTS,DOM
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 22747257
• Report Number: 2249723-2025-0003425
• Device Sequence Number: 4526659
• Product Code: DSP
• UDI-Device Identifier: 10607567108711
• UDI-Public: (01)10607567108711
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-UC-3023-83
• Device Catalogue Number: 0998-UC-3023-83
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2025
• Supplement Date Received by Manufacturer: 02/19/2026; 02/19/2026
• Initial Report FDA Received Date: 08/08/2025
• Supplement Report FDA Received Date: 02/19/2026; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown