MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, 3.1 EDITION; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-65
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the fse that the cardiosave intra-aortic balloon pump (iabp) helium gas rapidly decreased due to improper storage.After the helium cylinder was replaced with a new one, the issue reoccurred.The fse reported that they could not reproduce the issue.As a precaution, the gasket was replaced and it was confirmed that the helium was not leaking.There will be no part return.There was no patient involvement.
Additional Manufacturer Narrative
Event site name: (b)(6) hospital.Event site address: (b)(6).A getinge field service engineer (fse) inspected the unit and was able to verify the reported condition.No active leaks or reproducible faults were identified during the evaluation.It was suspected that the issue may have been related to the cylinder gasket.The fse replaced the gasket and monitored the system, confirming that the helium gas level remained stable following replacement.The results were satisfactory, and the unit was cleared for continued use.

• Brand Name: CARDIOSAVE HYBRID, 3.1 EDITION
• 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: 50943039
• Report Number: 2249723-2026-0004502
• Device Sequence Number: 9499511
• Product Code: DSP
• UDI-Device Identifier: 10607567113432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112372
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 09/30/2026
• 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