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 Codes	Pumping Problem (3016); Intermittent Communication Failure (4038)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during therapy the cardiosave intra-aortic balloon pump (iabp) stopped pumping.A patient was involved.No harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse arrived on site and analyzed device logs.Fault code # 106 (communication error in the software data center) was recorded several times.The fse was unable to replicate any issue when testing on a patient simulator and test catheter.Executive processor pcba was replaced as a precaution.B.17 software was reinstalled, 30psi and helium transducers were recalibrated.Product passed all functional and safety tests per manufacturer specifications.The replaced executive processor pcba will be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
E1 - event site name: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• 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: 50929478
• Report Number: 2249723-2026-0004473
• Device Sequence Number: 9734304
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• 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
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown