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

Model Number	0998-00-3023-68
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other contact site phone and email: (b)(6).Due to characterization limit e1: initial reporter: (b)(6).Event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by the customer that the cs300 intra-aortic balloon pump(iabp) equipment indicated that the cylinder needed to be replaced.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Updated field: b4, b5, b6, b7, d9, d10, g3, g6, h2, h3, h6(health effect ¿ impact codes), h11.
Event or Problem Description
It was reported by the customer that during the evaluation and technical testing period, the cs300 intra-aortic balloon pump(iabp) equipment indicated that the cylinder needed to be replaced.There was no patient involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4,g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.A getinge field service engineer (fse) inspected the unit and confirmed that the helium cylinder replacement alarm persisted following cylinder replacement.A functional testing was performed using a patient simulator and catheter for approximately 10 hours.Additional checks were completed in service mode.All testing, system pressure remained stable with no evidence of leakage.The helium tank was also calibrated.All results met factory specifications.No pressure abnormalities, leaks, or helium consumption issues were identified.No components were replaced during this visit.After prolonged testing, including multiple reservoir refill cycles, service mode evaluations, and helium tank calibration, no internal leaks, alarm system failures, or technical malfunctions were detected.The unit remained stable, within normal operating parameters, and helium consumption was consistent with expected performance.Based on all findings, the cs300 iabp is functioning within specifications and has been cleared for clinical use.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: 24127994
• Report Number: 2249723-2026-0000694
• Device Sequence Number: 10400105
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 03/27/2026

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: 0998-00-3023-68
• Device Catalogue Number: 0998-00-3023-68
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 03/07/2026; 03/26/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 03/18/2026; 03/30/2026
• 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.; UNKNOWN.
• Patient Sex: Unknown