MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-65
Medical Device Problem Codes	Inability to Auto-Fill (1044); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site name - (b)(6).Event site address - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use cs300 intra aortic balloon pump (iabp) had automatic filling error occurred.The pump was replaced to continue the treatment.There was no harm or injury reported.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, g6, h2, h3, h6 (investigation type, investigation findings, investigation conclusion), h11.Corrected fields: e1 initial reported name submitted by mistake).It was reported that during use, the cs300 intra-aortic balloon pump (iabp) had an autofill error.There was patient involvement and no injury or harm reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the issue was reproducible, caused by a pressure leakage from connector.The connection failure was due to aging deterioration.After correction, device passed the performance and safety checks according to factory specifications.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h11.Corrected field: e1 (initial reporter), h6 (medical device ¿ problem code, type of investigation).A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the issue was reproducible, caused by a pressure leakage from connector.The connection failure was due to aging deterioration.After correction, device passed the performance and safety checks according to factory specifications.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, JAPANESE, 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: 23093088
• Report Number: 2249723-2025-0003921
• Device Sequence Number: 18559715
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: (01)10607567108322
• 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): 04/17/2026

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: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• 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: 08/29/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 04/17/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/11/2025; 04/17/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown