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	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: e1: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer before use, that cs300 had faulty display.No patient involved.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11 corrected fields: h6(problem code, investigation findings, component code).
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected fields: g2.A getinge field service engineer (fse) was dispatched to evaluate the unit.To fix the issue the cable, coiled and cable, display to video rcvr were replaced.Repair was completed.Function and safetyvtests were performed with positive results.
Event or Problem Description
N/a.

• 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: 24562086
• Report Number: 2249723-2026-0001609
• Device Sequence Number: 8828470
• 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: Nurse
• Type of Report: Initial,Followup,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: 0998-00-3023-67
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 04/17/2026; 04/22/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/20/2026; 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown