MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-53
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cs300 intra-aortic balloon pump (iabp) had a helium leak issue.There was no patient involved.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5, h6 (type of investigation).
Event or Problem Description
It was reported that cs100 intra aortic balloon pump (iabp) had a helium leak issue.No patient harm reported.
Event or Problem Description
It was reported that cs300 intra aortic balloon pump (iabp) had a helium leak issue.No patient harm reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11 corrected fields: b5, b6, b7 ,d10, h6 (health effect impact code) cs100 upgraded to cs300 cs300 intra aortic balloon pump, english, 110v catalog #: 0998 00 3023 53 udi #: (b)(4).510k: k063525 a getinge field service engineer was dispatched to evaluate the unit.The reported that the system was missing a helium tank and a washer.However this was a non issue because the biomed supplied the spare tank and washer.The fse installed the new helium tank observed no audible sounds of helium leak upon new tank installation.System pressurized and helium tank closed to test for leakage.System lost no helium over half hour test.Unit shows no unexpected loss of helium during pumping.Unit passes all internal leakage tests.Product passed all functional and safety tests per manufacturer specifications.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V
• 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: 24065535
• Report Number: 2249723-2026-0000450
• Device Sequence Number: 18488742
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: (01)10607567107394
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/12/2026

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• 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: 12/24/2025
• Supplement Date Received by Manufacturer: 02/16/2026; 03/12/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 03/02/2026; 03/12/2026
• 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.; UNKNOWN.
• Patient Sex: Unknown