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

Model Number	0998-00-3023-67
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump had screen failure.No harm reported.
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (event site full name: (b)(6).Initial reporter: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h11.Corrected fields: e1 (mail id).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: g3, g6, e1 (initial reporter name), h2, h1.
Event or Problem Description
N/a.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump had screen failure.No patient involved.
Additional Manufacturer Narrative
Updated fields:b4,b5,b6,b7, d10, d9,g3,g6,h2,h3,h6(type of investigation, investigation findings, impact code,conclusion).H11 a getinge field service engineer (fse) was dispatched to evaluate the unit.Upon inspection, the fse reported that the defect described by the customer was not found.The work performed included a functional check and testing.The repair was completed, and all functional tests were successfully passed.The reported issue did not cause any damage or inconvenience to operators or patients.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 23753872
• Report Number: 2249723-2025-0004994
• Device Sequence Number: 20299903
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 01/27/2026

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: 0998-00-3023-67
• Device Catalogue Number: 0998-00-3023-67
• 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: 11/17/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 01/27/2026; 01/27/2026
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 01/14/2026; 01/27/2026; 01/27/2026
• 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.; N/A.; N/A.; UNKNOWN.
• Patient Sex: Unknown