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

Model Number	0998-00-3023-67
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump(iabp) had helium leak.There was no patient harm or injury reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Due to characterization limit e1: intial reporter name:(b)(6).Updated fields: b4, b5, b6, b7, b8, d9, e1 (initial reporter name and mail id), e3, g3, g6, h2, h3, h6(investigation type, investigation findings, investigation conclusion, component code), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the safety disk was expired and there was a leak at the helium cylinder connection.To remediate this, the fse replaced the safety disk and eliminated the leak.Upon repair, the unit passed all functional and safety tests per manufacturer specifications.
Event or Problem Description
It was reported by the customer that, during functional testing prior to patient use, the cs300 intra-aortic balloon pump exhibited a helium leak.There was no patient involvement at the time of the incident.

• Brand Name: CS300 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: 24430531
• Report Number: 2249723-2026-0001398
• Device Sequence Number: 18718101
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2026

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: 0998-00-3023-67
• Device Catalogue Number: 0998-00-3023-67
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 05/07/2026; 05/12/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/12/2026; 05/12/2026
• 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
• Patient Sex: Unknown