MAUDE Adverse Event Report: Datascope Corp. CS300 Intra-Aortic Balloon Pump, English, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3023-55
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, b6, b7, d10, g3, g6, g7, h2, h6 (type of investigation, investigation findings, investigation conclusion), h11 corrected fields: d5, e2, g2 reverted the contents of section a1 (patient id) to blank in mfg report number: 2249723 2026 0003702 a getinge field service engineer (fse) inspected the unit and determined that the failure was associated with the drive assembly.The equipment had exceeded the recommended service interval; therefore, replacement of the 5,000 hour preventive maintenance (pm) kit was also recommended.The device was removed from service.During the repair, the fse replaced the drive assembly and the 5,000 hour pm kit.Following the repair, all functional tests were performed and found satisfactory.The unit was monitored for approximately two hours, during which no recurrence of the low vacuum error was observed.The unit was subsequently returned to the customer in good working condition.

• Brand Name: CS300 Intra-Aortic Balloon Pump, English, 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: 50125838
• Report Number: 2249723-2026-0003702
• Device Sequence Number: 10560506
• Product Code: DSP
• UDI-Device Identifier: 10607567112541
• UDI-Public: (01)10607567112541
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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: 0998-00-3023-55
• Device Catalogue Number: 0998-00-3023-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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
• Patient Sex: Unknown