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

Model Number	0998-00-3023-61
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during maintenance testing cs300 intra-aortic balloon pump (iabp), it was found that the vacuum was below minimum values.After several tests, it was concluded that the problem was with the compressor itself.There was no patient involved.
Additional Manufacturer Narrative
Due to characterization limit e1: event site name: (b)(6).Event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.A getinge field service engineer (fse) evaluated the unit and concluded the problem originated in the compressor itself.Additionally, the connectors for the compressor showed signs of wear and were also replaced.Device passed the performance and safety checks according to factory specifications.
Additional Manufacturer Narrative
Mistakenly added telephone number in email tab.Please refer corrected tab event site telephone.Updated fields - b4, g3, g6, h2, h11 corrected field - e1.
Additional Manufacturer Narrative
Event site telephone (b)(6), updated fields - b3, b4, g3, g6, h2, h11, corrected field - e1, g2.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: 24710847
• Report Number: 2249723-2026-0001886
• Device Sequence Number: 17664279
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/14/2026

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: Other
• Device Model Number: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/08/2026; 04/14/2026; 04/14/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/10/2026; 04/14/2026; 04/14/2026
• 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
• Patient Sex: Unknown