MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID, 3.1 EDITION; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-65
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during routine check by the customer, the cardiosave intra-aortic balloon pump (iabp) malfunctioned and battery 1 was not charging, even though the power cable was connected.There was no patient involvement reported.A getinge field service engineer (fse) evaluated the unit for the reported malfunction.Upon testing, it was found that the base for power management (ac/dc switching, charging control) has failed.Failure has been detected in the power management board.After replacement of the power management board, the fse performed multiple discharge and charge tests and the results were satisfactory.Both batteries 1 and 2 were able to operate for more than 80 minutes.
Additional Manufacturer Narrative
E.(b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID, 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 50539263
• Report Number: 2249723-2026-0004093
• Device Sequence Number: 15930338
• Product Code: DSP
• UDI-Device Identifier: 10607567113432
• UDI-Public: (01)10607567113432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: Other
• Device Model Number: 0998-00-0800-65
• Device Catalogue Number: 0998-00-0800-65
• 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: 08/10/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown