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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Due to characterization limit e1: (b)(6) updated field: b4, g3, g6, e2, e3, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11 correction field: d10, e1(initial reporter), g2, h6 (health effect impact codes) a getinge field service engineer (fse) evaluated the unit and confirmed the reported fault code.During troubleshooting, the fse cleaned the transducer contacts on the circuit board, which resolved the issue.Following the repair, all required functional and safety testing was performed and passed successfully.The unit was returned to the customer for clinical use.Fault logs are attached to the investigation for review.

• 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: 50708706
• Report Number: 2249723-2026-0004233
• Device Sequence Number: 10598983
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Report Date (Section B): 10/01/2026

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: Health Professional
• 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: 08/21/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/10/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown