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 Codes	Inability to Auto-Fill (1044); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1, e1 event site full name is (b)(6).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 has been shut down but has not provided further information.However, the technical inspection indicates that the equipment has already reached 5,000 hours of effective use (currently 16,388.8 hours).This indicates that the 5,000-hour engine rebuild kit must be replaced, as indicated by the manufacturer, to ensure the proper vacuum and pressure supply that the engine should provide.There is no evidence of actual or potential damage or death.
Additional Manufacturer Narrative
Updated fields: b4, b5, d8, d9, e1 (initial reporter, event site address, and event site telephone), e3, g1 (contact person mfg site), g3, g6, h2, h3, h6 (medical device problem code, type of investigation, investigation findings, component codes and investigation conclusions), h11.Due to character limit in block e1 initial reporter: (b)(6).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, the equipment was disassembled to perform the following activities check internal hoses for vacuum leaks, adjust drive sensor (0 to 380 mmhg), adjust atmospheric sensor (562 mmhg), adjust shuttle sensor (0 to 100 mmhg), verify internal pressure and vacuum pressures, service leak tests: autofill, purge (k3 and k5), operating valves (k6, k6a, k7, and k8), safety and performance valves.All pressure sensor values showed a deviation of 50 mmhg, which was corrected and adjusted to the manufacturer's permitted values.All service tests passed successfully; however, it was observed that the equipment had already reached 5,000 hours of effective use (currently 16,388.8 hours).This indicates that the 5,000-hour engine rebuild kit must be replaced, as indicated by the manufacturer, to ensure the correct vacuum and pressure supply that the engine should provide.The console was tested with a simulator and test balloon to verify its general operation, which was recorded without errors or alarms.The customer is recommended to leave the equipment counter pulsing for more than 24 hours with the simulator to verify that no errors or alarms appear.
Event or Problem Description
It was reported during use that the cs300 intra-aortic balloon pump has been shutdown.However, the technical inspection indicates that the equipment has already reached 5,000 hours of effective use (currently 16,388.8 hours).This suggests that the 5,000-hour engine rebuild kit must be replaced, as recommended by the manufacturer, to ensure the proper vacuum and pressure supply that the engine should provide.Additionally, error 57 autofill failure was encountered.There is no evidence of actual or potential damage or failure.No harm reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: g2 (report source).
Event or Problem Description
N/a.

• 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: 22042801
• Report Number: 2249723-2025-0002258
• Device Sequence Number: 8880610
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2025

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: 0998-00-3023-57
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 09/25/2025
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 09/24/2025; 09/25/2025
• 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