MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-61
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event site postal code -(b)(6).A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) unit observed electrical test failure.Upon further testing it was found that the compressor needed to be replaced.Issue was found by the customer before use, there was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: g7.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to characterization limit e1 event site name: (b)(6).Due to characterization limit e1 event site address: (b)(6).Updated fields: b4, e1(initial reporter, event site telephone, event site email), e2, e3, g3, g6, h2, h6(type of investigation, investigation findings, component code, conclusion), h11.Corrected field: b6, b7, e1(event site name, event site address).A getinge field service engineer (fse) inspected the unit and replaced the compressor, the error was resolved.During testing, a louder noise was detected from valves k7 / k8.The fse also replaced the drive manifold.The unit passed all functional tests.
Additional Manufacturer Narrative
Updated fields: b6, b7, b8, e1 (initial reporter, event site telephone, event site email), e2, e3, g6, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected fields: b5, g2, h6 (medical device problem code).Revert the contents of section e1 (event site postal code) to blank as not required for outside us.A getinge field service engineer (fse) inspected the unit and replaced the compressor, the error was resolved.During testing, a louder noise was detected from valves k7 / k8.The fse also replaced the drive manifold.The unit passed all functional tests.
Event or Problem Description
It was reported that before use, the cs300 intra aortic balloon pump (iabp) displayed an electrical test failure code # 50 (motor speed out of specification).No patient was involved, and no harm was reported.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: 24444409
• Report Number: 2249723-2026-0001427
• Device Sequence Number: 21443379
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2026

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/17/2026; 03/30/2026; 03/30/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/25/2026; 04/01/2026; 04/13/2026
• 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: N/A.
• Patient Sex: Unknown