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	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump was beeping.No patient involved.No harm occurred.
Event or Problem Description
It was reported that during use the cs300 intra aortic balloon pump (iabp) unit was beeping.Patient involved and no harm reported.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11 corrected fields: b5, b6, b7, d10.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h6 (type of investigation, investigation finding, conclusion), h11.A getinge field service engineer (fse) unit was able to augmentate and complete and autofill.Upon further inspection safety disk was passed its replacement hours of 13,294 hrs.Unit currently shows at (b)(4).Safety disk ((b)(6)) replaced.Unit was set to augmentate for 1hr successfully.Unable to replicate alarm "beep".Device passed all functional and safety tests according to factory specifications.Device was returned to customer.
Event or Problem Description
N/a.

• 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: 21354255
• Report Number: 2249723-2025-0000647
• Device Sequence Number: 8950360
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2025

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: 01/23/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 10/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 10/29/2025; 10/29/2025
• 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