MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-65
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that during use the cs300 intra-aortic balloon pump (iabp) had abnormal display (vertical lines, white haze) when powered on.No harm reported.
Additional Manufacturer Narrative
(b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9(device available for eval), g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.Additional contact person name: (b)(6).After multiple gfe attempts asking for the service report information we are left unaware of what repairs were done.If any pertinent information is received, investigation will be reopened and updated.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields:b4, g3, g6, h2, h11.Corrected field: b6, d1, d4 (version or model, catalog, unique identifier), e1 (initial reporter name).After submitting the estimate, the hospital contacted us to say that no repairs were necessary, so the situation was closed without any work being done.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• 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: 23082668
• Report Number: 2249723-2025-0003911
• Device Sequence Number: 15905706
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: (01)10607567108803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/13/2026

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-UC-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 01/06/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 11/27/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: UNKNOWN.
• Patient Sex: Unknown