MAUDE Adverse Event Report: Datascope Corp. CS300 Intra-Aortic Balloon Pump, English, 110V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3023-53
Medical Device Problem Codes	Leak/Splash (1354); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that the cs300 intra-aortic balloon pump (iabp) is not working.It is unknown when the malfunction occurred.There is no information about patient involvement.No harm is reported.Customer stated ¿broken¿ not definitive failure stated.Tested and examined logs observed numerous ¿leak in iab catheter¿.No patient information or harm reported at time of service visit.Performed all leak tests and passed to specifications.Unit passed all functional and safety tests per factory specifications, returned to customer.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CS300 Intra-Aortic Balloon Pump, English, 110V
• 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: 50815057
• Report Number: 2249723-2026-0004359
• Device Sequence Number: 13314680
• Product Code: DSP
• UDI-Device Identifier: 10607567107882
• UDI-Public: (01)10607567107882
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/18/2026
• 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