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

Model Number	0998-00-3023-64
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limit in e1 initial reporter name is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) no longer inflates.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected field: e1 (event site name) due to character limit in block e1 full event site name: (b)(6).
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), h11.Corrected field: e1 event site name and address, b5, b6, b7, d10, h6 health effect ¿ clinical code, health impact code.A getinge field service engineer (fse) checked and found an issue with the vacuum membrane on the compressor.The customer was provided a quote for this repair but no information about the repair as well as safety/functional tests was made available.Multiple gfes were asked to get a better understanding of this complaint if more information becomes available the record will be updated.During preventative maintenance the 2500 kit was replaced due to an error to the vacuum membrane on the compressor.
Event or Problem Description
The cs300 intra-aortic balloon pump (iabp) no longer inflates.The customer detected an a poor vacuum during routine check.
Event or Problem Description
It was reported by customer during routine check, detected an a poor vacuum, the cs300 intra-aortic balloon pump (iabp) no longer inflates.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (health effect ¿ clinical code), h11 corrected field - b5, d10.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 22356137
• Report Number: 2249723-2025-0002771
• Device Sequence Number: 8706392
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: (01)10607567108308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 12/26/2025

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: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• 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: 06/16/2025
• Supplement Date Received by Manufacturer: 12/10/2025; 12/23/2025; 12/26/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 12/15/2025; 12/23/2025; 12/26/2025
• 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: BALLOON.; N/A.; UNKNOWN.
• Patient Sex: Unknown