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 Codes	No Device Output (1435); Application Network Problem (2879)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by getinge field service engineer (fse) that during product training, the cardiosave intra-aortic balloon pump (iabp) malfunctioned.Device freeze, was unable to switch between pressure to ecg trigger.No patient involved.No harm reported.Device was unable to trigger alarms.After disconnecting iab from the pump, cardiosave continued pumping without an alarm.After restart device worked as expected.Pump was reported to be updated to d.03 software the day before.
Additional Manufacturer Narrative
Event site name: (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: 50930089
• Report Number: 2249723-2026-0004477
• Device Sequence Number: 10722681
• Product Code: DSP
• UDI-Device Identifier: 10607567108414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112372
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: Other
• 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?: Yes
• 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: 02/10/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown