MAUDE Adverse Event Report: Datascope Corp. CARDIOSAVE HYBRID W/ E/F PLUG; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-0800-55
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during routine check the cardiosave intra-aortic balloon pump (iabp) shut down.No patient involved.No harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that a review of the system logs found no anomalies, alerts, or prior error codes that would account for the reported shutdown.The device underwent inspection and functional testing, including battery charging/discharging verification, battery operation checks, error review, and confirmation of the most recent battery maintenance ((b)(6)2026).All tests were successfully completed, the device remained operational during testing with no shutdowns observed, and no issues were identified.The equipment is functioning correctly and is suitable for clinical use.
Additional Manufacturer Narrative
Initial reporter: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CARDIOSAVE HYBRID W/ E/F 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: 50816592
• Report Number: 2249723-2026-0004363
• Device Sequence Number: 10127514
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• UDI-Public: (01)10607567108414
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 0998-00-0800-55
• Device Catalogue Number: 0998-00-0800-55
• 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: 08/31/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown