MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, TYPE G PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-52
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that prior to use, the cardiosave intra-aortic balloon pump (iabp) is leaking helium gas.No patient involved.No harm was reported.The fse was dispatched to evaluate the unit.It was reported that screen showing helium is empty.Fse couldnt get screen to show an empty bottle.Full bottle on machine and half bottle also on site.Fse tried both bottles and both showing to have gas on analog display and digital.There was a slight leak when unit was in the cart, maybe down to o-ring.Replaced this o-ring and completed leak checks.All within manual specifications.Functional tests done and seen to pass.Completed repair successfully.Product passed all functional and safety tests per manufacturer specifications.
Additional Manufacturer Narrative
Initial reporter: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, TYPE G PLUG
• 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: 50731296
• Report Number: 2249723-2026-0004257
• Device Sequence Number: 10647792
• Product Code: DSP
• UDI-Device Identifier: 10607567108438
• UDI-Public: (01)10607567108438
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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: 0998-00-0800-52
• Device Catalogue Number: 0998-00-0800-52
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown