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	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an inspection by the customer, cs300 intra-aortic balloon pump (iabp) unit's screen display was flickering.There was no patient involvement.
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h6, h11.Corrected fields: h11.A getinge field service engineer (fse) inspected the unit and explained that the device is at the end of support and therefore will not be repaired.The case was handed over to the sales representative to discuss replacement.
Additional Manufacturer Narrative
Updated fields: b4, d8, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.

• 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: 23663994
• Report Number: 2249723-2025-0004851
• Device Sequence Number: 8845697
• 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): 12/05/2025

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: 0998-00-3023-65
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 12/05/2025
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 12/05/2025; 12/05/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown