MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-67
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions, event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that cs100 intra-aortic balloon pump (iabp) had failed helium filling.There was no patient involvement reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h2 , h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11 corrected fields- e initial reporter it was reported that before use, the cs100 intra-aortic balloon pump (iabp), failed during the helium filling process.There was no patient involvement reported, and no patient injury or harm occurred.A getinge field service engineer evaluated the unit for the reported condition.During the evaluation, it was confirmed that the helium outlet fitting was broken, which caused the helium filling failure.Corrective action included replacement of the helium outlet fitting.Following the repair, operational testing was performed and confirmed positive results.No fault logs were available for review.All functional and safety checks were completed successfully in accordance with factory specifications.The equipment was confirmed to be operating properly and cleared for clinical use.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11 corrected field - h6 (type of investigation, investigation findings, component codes).It was reported that before use, the cs100 intra-aortic balloon pump (iabp), failed during the helium filling process.There was no patient involvement reported, and no patient injury or harm occurred.A getinge field service engineer evaluated the unit for the reported condition.During the evaluation, it was confirmed that the helium outlet fitting was broken, which caused the helium filling failure.The fse replaced the helium outlet fitting and the issue was resolved.Following the repair, operational testing was performed and confirmed positive results.No fault logs were available for review.All functional and safety checks were completed successfully in accordance with factory specifications.The equipment was confirmed to be operating properly and cleared for clinical use.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 23401742
• Report Number: 2249723-2025-0004457
• Device Sequence Number: 9946095
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K031636
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2026

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 10/06/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 04/02/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 01/20/2026; 04/02/2026
• 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