MAUDE Adverse Event Report: DATASCOPE CORP. CARDIOSAVE HYBRID TYPE J PLUG; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-0800-32
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to characterization limit, e1 event site name: (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cardiosave intra-aortic balloon pump (iabp) turned off during use.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusion), h11.Corrected fields - e3, g2.A getinge field service engineer (fse) was dispatched to evaluate the unit.Upon arrival at the location, the equipment was on and functioning normally.Therefore, the equipment was left to perform a battery test.On another visit it was found that the equipment shut down again without any manual activation.It was verified in the service logs that the equipment had presented some faults, one of which resulted in shutting down without any manual activation.The fse reinstalled the software and cleaned of the internal boards was performed, along with a check of the connected cables.The equipment was placed in service mode and a battery test was performed.It was verified that the system completed the battery test and the unit did not shut down, reinforcing that the software reinstallation had the expected effect.Product passed all functional and safety tests per manufacturer specifications.

• Brand Name: CARDIOSAVE HYBRID TYPE J 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: 24662506
• Report Number: 2249723-2026-0001815
• Device Sequence Number: 15775298
• Product Code: DSP
• UDI-Device Identifier: 10607567111117
• UDI-Public: (01)10607567111117
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2026

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: 0998-00-0800-32
• Device Catalogue Number: 0998-00-0800-32
• 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: 03/02/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown