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

Model Number	0998-00-0800-53
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: h2, h11, g6, g3, h6 an investigation was conducted reagarding failure of the helium leak in the cardiosave intra-aortic balloon pump (iabp).Based on the available information and fse investigation results, the reported helium leak condition was confirmed.The customer was found to be using plastic helium tank seals, which were replaced with the appropriate seals.The replaced seals will not be returned.Additionally, the easily accessible helium connections to the cart¿s helium regulator were tightened.The most probable root cause is component reliability.This issue continues to be monitored within the manufacturer¿s quality system.
Event or Problem Description
It was reported by the customer that the cardiosave intra-aortic balloon pump (iabp) malfunctioned.Helium tank leaking multiple times has been reported.There was no patient involvement reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that device found to have a leak of approximately 15 psi in 5 minutes.Found staff using plastic tank seals, which were replaced.Tightened the easily accessible helium connections to the cart¿s helium regulator and tested again.Product passed all functional and safety tests per manufacturer specifications.Returned to customer.
Additional Manufacturer Narrative
Event site name: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Event or Problem Description
N/a.

• Brand Name: CARDIOSAVE HYBRID, TYPE B 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: 50929123
• Report Number: 2249723-2026-0004469
• Device Sequence Number: 15829784
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• UDI-Public: (01)10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• 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: 09/08/2026
• Supplement Date Received by Manufacturer: 09/26/2026
• Initial Report FDA Received Date: 09/29/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown