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	Gas/Air Leak (2946); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) malfunctioned.No harm reported.Unit stopped working while alarming and was unable to troubleshoot.Patient was put on another known good unit to avoid therapy delay.Onsite, fse could not confirm what alarm was alarming during use.Initial power up and run of unit had no issues.However, there was a gas loss alarm along with technical error 118 in the background.As a pre caution the power management board was replaced for error code 118.Unit was then ran for a couple hours and no issues occurred or alarms.Verified unit passed manufacturer specs, unit returned to customer.No other patient information provided.Fse completed repair successfully.Product passed all functional and safety tests per manufacbturer specifications.
Additional Manufacturer Narrative
Initial reporter: (b)(6).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: 50942626
• Report Number: 2249723-2026-0004491
• Device Sequence Number: 15850353
• Product Code: DSP
• UDI-Device Identifier: 10607567108391
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 09/30/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown