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 Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site address-1 (b)(6).Event site name- (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that, cs300 intra-aortic balloon pump (iabp) had helium leak.
Event or Problem Description
It was reported by fse that the cs300 intra-aortic balloon pump (iabp) continued to leak gas.There was no patient involvement and no injury or harm reported.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11 full event site rep name: (b)(6).Corrected data: b5, d5, e1(event site name and email), e2, e3, e4, g2, h6 (health effect ¿ impact codes).
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h1, h2, h11, h3, b5, d9, h6.(type of investigation, investigation findings, component codes, investigation conclusions).A getinge field service engineer (fse) evaluated the unit.The fse reported that the newly procured helium regulator (0119-00-0208) also exhibited helium gas leakage.It was replaced with another helium regulator and the repair was able to be completed.Device passed the performance and safety checks according to factory specifications.The following investigation was performed by (b)(4), technician of the maquet failure analysis and testing dept.(fat) wayne, nj cf 16 mar 2026.The failure analysis and testing dept.Received part number 0119-00-0208 helium regulator assy serial number (b)(6) with a reported unit failure of gas leak from helium regulator.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed part number 0119-00-0208 helium regulator assy serial number (b)(6) into the cs300 test fixture serial number (b)(6) and tested the helium regulator to factory specifications per the cs300 service manual part number 0070-00-0689 rev.W.The fat dept.Performed the helium checks.The fat dept.Could not replicate the complaint of a gas leak from the helium regulator.The helium regulator passed testing.Retaining the helium regulator in the fat dept.Per procedure number (b)(4).
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) continued to leak gas.There was no injury or harm reported.

• 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: 23799060
• Report Number: 2249723-2025-0005075
• Device Sequence Number: 5080388
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2026

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?: No
• Operator of Device: Other
• Device Model Number: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 03/25/2026; 03/26/2026
• Initial Report FDA Received Date: 12/14/2025
• Supplement Report FDA Received Date: 03/26/2026; 03/26/2026
• 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