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 Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during schedule pm by getinge fse the cs300 intra aortic balloon pump (iabp) compressor making loud rattling noise.There was no patient involvement or adverse event reported.The fse replaced noisy compressor.All functional and safety checks to meet factory specifications were performed.
Additional Manufacturer Narrative
A getinge field service engineer (fse) replaced noisy compressor.All functional and safety checks to meet factory specifications were performed.The failure analysis and testing dept.Received compressor with a reported unit failure of the compressor making a loud rattling noise.The fat performed a visual inspection and found the part to be in good condition.The fat installed the part into cs300 test fixture and tested the part to factory specifications per the cs300 service manual.Confirmed that the part would make a rattling sound during operation.Since this is a very old compressor, the probable root cause is expected wear and tear.Retaining the part in the failure analysis and testing department.

• 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: 50942855
• Report Number: 2249723-2026-0004496
• Device Sequence Number: 10429037
• Product Code: DSP
• UDI-Device Identifier: 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Other
• Device Model Number: 0998-00-3023-53
• Device Catalogue Number: 0998-00-3023-53
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sex: Unknown