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

Model Number	0998-UC-3023-53
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
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 the cs300 intra aortic balloon pump(iabp) had optical sensor failure message on the display.There had patient involvement.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields : b3, e3, g3, g6, h2.H6(type of investigation, investigation findings, investigation conclusions), h11.The fse tested the unit using a fiber optic tester, and all results were within factory specifications.Additional testing was repeated five times, with consistent passing results.The fse then disassembled the unit, cleaned the fiber optic bulbs, inspected all connections, and reassembled the system.Post-maintenance testing confirmed normal operation.A full functional and calibration check was completed, with the unit meeting all factory specifications.The unit was further evaluated by running it on a test balloon for approximately 30 minutes, during which no alarms or faults were observed.The unit was returned to service, as the reported issue could not be duplicated.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-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: 24797007
• Report Number: 2249723-2026-0002061
• Device Sequence Number: 21219556
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: (01)10607567108704
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2026

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-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Supplement Date Received by Manufacturer: 05/01/2026; 05/15/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/08/2026; 05/15/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown