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	09/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields: b4, g6,h2,h11 corrected fields : g3 this mdr is being updated based on findings identified during retrospective review under capa.The updated parent investigation for the reported gas loss issue incorporated capa findings and determined that the reported alarm condition could not be reproduced.
Event or Problem Description
It was reported that during use the cardiosave intra aortic balloon pump (iabp) displayed gas loss in iab circuit.There was no reported harm or injury.Fse evaluated the unit and noticed that, the compressor was sluggish and slow to come up to pressure.The compressor and the expired safety disk and tidal volume disk were replaced.Unit passed all the tests.
Additional Manufacturer Narrative
Due to charactreisation limit e1(initial reporter): everell sinclair a getinge field service engineer (fse) was dispatched to evaluate the unit, they noticed the compressor is sluggish and is slow to come up to pressure, compressor caused false leak alarms.The fse replaced the compressor and the expired safety disk and tidal volume disk.The unit returned to normal function as well as passed all safety and functional tests.The failure analysis and testing department received the following part associated with this complaint: compressor scroll this part was received with a reported unit failure message of gas loss alarm.The failure analysis and testing dept.Performed a visual inspection, and part looks in good condition.Installed compressor scroll into the cardiosave test fixture and tested to the cardiosave service manual.Performed functional tests and passed.Also, pumped the cardiosave test fixture for 3 hours and the fat dept.Did not observe gas loss alarm message on screen.The fat dept.Could not verify the failure message of gas loss alarm.Compressor scroll passed testing.Retaining compressor scroll in the fat dept.Per procedure.

• 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: 50942853
• Report Number: 2249723-2026-0004497
• Device Sequence Number: 10429035
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• 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: 0998-00-0800-53
• Device Catalogue Number: 0998-00-0800-53
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2025
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/30/2026
• Supplement 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: Unknown
• Patient Sex: Unknown