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	08/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - event site postal code: h3t 1e2.\ \ upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the customer that during use, the cardiosave intra-aortic balloon pump (iabp) helium gas loss message occurred.There was patient involvement.No harm was reported.It was reported that pump was replaced, the clinical staff kept the same balloon and replaced the cardiosave unit.
Additional Manufacturer Narrative
Updated fields: h2, h11, g6, g3, b5, h6 (type of investigation, component codes), d9, h3\ upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
It was reported by the customer that during use, the cardiosave intra-aortic balloon pump (iabp) helium gas loss message occurred.There was patient involvement.No harm was reported.It was reported that pump was replaced, the clinical staff kept the same balloon and replaced the cardiosave unit.The getinge fst was dispatched to evaluate the unit.It was reported that no helium gas loss or fault nr 53 were observed.The software version was reinstalled as a precaution.Pim module, safety disk, power management board and solenoid board were replaced.The cardiosave device has been successfully maintained.It is now ready for clinical 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: 50752300
• Report Number: 2249723-2026-0004276
• Device Sequence Number: 9361542
• Product Code: DSP
• UDI-Device Identifier: 10607567113432
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2024
• 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: Unknown
• Patient Sex: Unknown