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

Model Number	0998-00-3023-58
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that during use on the patient, the cs300 intra-aortic balloon pump (iabp) had alarm on the display.There was no harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9, g1(contact person ¿ mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected fields: e1(event site telephone).A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse replaced the drive manifold and vent valve to resolve the issue.All functional and safety checks performed to meet factory specifications.Equipment suitable for clinical use.
Event or Problem Description
It was reported that during use on patient the cs300 intra artic balloon pump (iabp) had an unknown alarm on display.There was no patient harm or injury reported.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, SPANISH, 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: 21616670
• Report Number: 2249723-2025-0001227
• Device Sequence Number: 8535636
• Product Code: DSP
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/17/2026

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 09/08/2026
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 10/30/2025; 09/17/2026
• 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