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

Model Number	0998-00-3023-67
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) unit observed problem with display does not work.There was no patient harm or injury reported.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h11.Corrected field - b5, b6, b7, h6 (investigation findings, component codes, health effect impact codes).
Event or Problem Description
It was reported by the customer that the cs300 intra-aortic balloon pump display was not working while the device was in standby mode.No patient was involved at the time of the event.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Correction field: d1, d3, g1, h6(component codes).Updated field: b4, d9, g3, g6, h2, h3, h6(type of investigation, investigation findings, investigation conclusions), h11.A getinge field service engineer fse was dispatched to the site to evaluate the unit.Upon arrival, fse discovered that the display is out of synchronization.Fse cleaned and deoxidated the spiral cable connector display.The repair was completed and the device passed all functional and safety tests with a positive outcome.The device has been returned to the customer for clinical use.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, ITALIAN, 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: 24399461
• Report Number: 2249723-2026-0001354
• Device Sequence Number: 13198601
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 0998-00-3023-67
• Device Catalogue Number: 0998-00-3023-67
• 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: 01/29/2026
• Supplement Date Received by Manufacturer: 03/22/2026; 04/13/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2008
• 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: NA.
• Patient Sex: Unknown