MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-64
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the character limit in the e1 section, the full event site name is (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cardiosave intra-aortic balloon pump (iabp) had shut down when the device was turned on.The device shuts down as soon as it is turned on.It was connected to a patient and started to beep.The device was removed from the patient.No harm or injury to the patient was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields - b4, e1, e2, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11.Additional point of contact (b)(6).A getinge field service engineer (fse) was dispatched to evaluate the unit.It was found that the device was not plugged in.The battery charging switch was in the "off" position and there was an alarm for low battery.The iabp was plugged in and the console worked.Preventively, the fse replaced the batteries (0146-00-0039).Device conforms to the manufacturer's recommendations and tolerance ranges.Maintenance and validation were completed successfully.Product passed all functional and safety tests per manufacturer's specifications.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 220V
• 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: 23520491
• Report Number: 2249723-2025-0004644
• Device Sequence Number: 18568028
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: (01)10607567108308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063525
• 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,Followup
• Report Date (Section B): 01/01/2026

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: Health Professional
• Device Model Number: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/01/2026
• 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