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 Codes	Inability to Auto-Fill (1044); No Device Output (1435)
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
Updated fields: b3, b4, d9, e1 (initial reporter, telephone, event site mail), e3, g3, g6, h2, h3, h6 (type of investigation, investigation findings, conclusion), h11.A getinge field service engineer (fse) found errors in the autofill logs.The 5000 hour kit has already been changed this summer.The vacuum reading on the x2 is 136 mmhg, when it should be below 100.The compressor needs replacing.Quote in progress.No ecme.Customer don't want to repair device.In future if we receive any repair information will reopen and update the investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer during the routine check that the cs300 intra-aortic balloon pump(iabp) had a fiber-optic malfunction.There was no patient involved.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected fields - b5, h6(medical device ¿ problem code, investigation findings).
Event or Problem Description
It was reported by the customer during the routine check that the cs300 intra-aortic balloon pump(iabp) had an autofill failure alarm.There was no patient involved.

• 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: 23532844
• Report Number: 2249723-2025-0004679
• Device Sequence Number: 15719614
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2026

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: 02/25/2026; 03/09/2026
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 03/09/2026; 03/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown