MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-67
Medical Device Problem Codes	Filling Problem (1233); Suction Problem (2170); Gas/Air Leak (2946)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other contact person: mr.(b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that during routine check the cs300 intra-aortic balloon pump (iabp) failed the k6 k6a k7 k8 test and it isn't able to create vacuum.There was no patient involvement.
Additional Manufacturer Narrative
Another contact info: (b)(6).Corrected fields: e1(event site telephone) updated fields: updated fields: b4,g3,g6,h2,h6(type of investigation, investigation findings,component codes,investigation conclusions),h11 it was reported that during pre use check, the cs300 intra-aortic balloon pump (iabp) had a k6, k6a, k7, k8 leak test failed.There was no patient involvement reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the drive manifold assembly was defective and was replaced.The unit passed all functional and safety tests then returned unit back to customer.The failure analysis and testing dept.Received manifold, drive with a reported unit failure of fails k6,k6a,k7,k8 leak tests.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 manifold, drive into the cs300 test fixture and tested the drive manifold to factory specifications per the cs300 service manual.The fat dept.Proceeded to perform the k6,k6a,k7,k8 leak tests.The drive manifold failed testing.The fat dept.Replicated the complaint of the drive manifold failing the k6,k6a,k7,k8 leak tests.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g1, g3, g6, h2, h6, h11.Corrected fields: h6(product problem), investigation conclusion.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V
• 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: 23788296
• Report Number: 2249723-2025-0005062
• Device Sequence Number: 5522019
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2026

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: 0998-00-3023-67
• Device Catalogue Number: 0998-00-3023-67
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 03/05/2026; 04/21/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 03/10/2026; 04/21/2026
• 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: N/A.
• Patient Sex: Unknown