MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE RESCUE, 3.1 EDITION; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-85
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported after maintenance that a cardiosave intra-aortic balloon pump (iabp) had ai manifold test failed the test step: membrane leak of 7 mmhg.No patient was involved.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6 (type of investigation, investigation findings, component code, investigation conclusion), h11.Corrected field: b5.The getinge field service engineer (fse) that encountered the issue replaced the defective save disk.All manifold test performed, everything ok.
Event or Problem Description
It was reported after maintenance that a cardiosave intra-aortic balloon pump (iabp) had all manifold test failed the test step.Membrane leak of 7 mmhg.No patient was involved.

• Brand Name: CARDIOSAVE RESCUE, 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21696441
• Report Number: 2249723-2025-0001444
• Device Sequence Number: 9234345
• Product Code: DSP
• UDI-Device Identifier: 10607567113449
• UDI-Public: (01)10607567113449
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: Other
• Device Model Number: 0998-00-0800-85
• Device Catalogue Number: 0998-00-0800-85
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 05/22/2025
• 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