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

Model Number	0998-00-3023-45
Medical Device Problem Codes	Inability to Auto-Fill (1044); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional e1(initial reporter)- (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that a cs300 intra aortic balloon pump (iabp) experienced an automatic inflation failure and drive valve group test failure.No patients were involved.
Additional Manufacturer Narrative
Additional information: initial reporter name: (b)(6).Updated fields: b4, d9, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.A getinge field service engineer (fse) stated that the drive valve assembly test also failed.Fse replaced the drive valve assembly.The equipment has passed all factory-specified performance and safety tests.The equipment has been delivered to the customer and was ready for clinical use.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, CHINESE, 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: 24244420
• Report Number: 2249723-2026-0001059
• Device Sequence Number: 13159995
• Product Code: DSP
• UDI-Device Identifier: 10607567108575
• UDI-Public: (01)10607567108575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/09/2026

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: 0998-00-3023-45
• Device Catalogue Number: 0998-00-3023-45
• 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: 01/11/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/09/2026
• 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