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

Model Number	0998-00-3023-65
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6).Event site city: (b)(6).Event site telephone: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported in cs300 intra aortic balloon pump (iabp), there was leak in iab circuit alarm, there was no patient harm or injury.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions, component codes),h11.A getinge field service engineer (fse) checked and replaced drive assembly , repair completed.Functional tests performed with positive outcome.The equipment was returned to the customer for clinical use.
Additional Manufacturer Narrative
Updated fields: b4,d9(return to manufacture date),g3, g6,h2,h6(type of investigation),h11 corrected field: h6(component codes).It was reported that during use the cs300 intra-aortic balloon pump (iabp) unit had leak in iab circuit.After the alarm gas loss in iab circuit was generated, this reported iabp unit was replaced with another one.Iabp therapy was continued and completed with the second iabp unit without any further issues.There was patient involvement however, no adverse event reported for the issue.A getinge field service engineer (fse) checked and replaced purge valve, repair completed.Functional tests performed with positive outcome.The equipment was returned to the customer for clinical use.The failure analysis and testing dept received part number of purge valve assy serial number with a reported unit failure of iab circuit leak occurred.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 purge valve assy angar into the cs300 test fixture and tested the purge valve assy to factory specifications per the cs300 service manual.The fat dept.Performed an autofill to pump the cs300.After four hours of run time, the fat dept.Could not replicate an iab circuit leak.The purge valve assy passed testing.Retaining the purge valve assy in the fat dept.The most probable root cause is excessive stress or fatigue.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: 23462860
• Report Number: 2249723-2025-0004548
• Device Sequence Number: 18709420
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: (01)10607567108322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/24/2026

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: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/13/2025; 02/20/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 12/28/2025; 03/06/2026
• 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: IAB CATHETER.
• Patient Sex: Unknown