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 Code	Inability to Auto-Fill (1044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported that during use the cs300 intra-aortic balloon pump (iabp) had an automatic inflation malfunction.Patient involvement was reported, however no patient harm or injury occurred.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field : b4 , g3 , g6 , h2 , h11.Corrected field : h6 ( component codes ).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to characterization limit e1 event site name is (b)(6).Updated fields: b4, d9, e1(initial reporter), e2, e3, g2, g3, g6, g7, h2, h3, h11 , d10 , d5 , h6(investigation findings, type of investigation, investigation conclusions), h11.A getinge field service engineer (fse) inspected the unit on-site, and no fault was identified.The unit passed the pre use inspection as well as all manufacturer specified performance and safety tests.The unit was returned to the customer and is considered suitable for clinical use.

• 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: 24922939
• Report Number: 2249723-2026-0002365
• Device Sequence Number: 9153847
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2026

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: 04/12/2026
• Supplement Date Received by Manufacturer: 05/10/2026; 05/16/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 05/15/2026; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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: GETINGE IAB
• Patient Sex: Unknown