MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-57
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/16/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Due to character limitation in e1, full event site name is (b)(6).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) shut down during the patient's transfer from the coronary icu to the ct scan.Event occurred on (b)(6) 2025, 4:30 pm.The patient died, although it is unknown if it was due to the equipment.
Additional Manufacturer Narrative
Updated fields - b2, b4, d9, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.Inspection and cleaning of electrical, electronic, and pneumatic systems.Internal and external cleaning of the equipment.A test was performed in service mode and passed without any issues.All functional test were performed.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 110V
• 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: 22033332
• Report Number: 2249723-2025-0002232
• Device Sequence Number: 8747749
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: (01)10607567108254
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-00-3023-57
• Device Catalogue Number: 0998-00-3023-57
• 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: 05/02/2025
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 02/23/2026
• 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.
• Outcome Attributed to Adverse Event: Death
• Patient Age: 63 YR
• Patient Sex: Male