MAUDE Adverse Event Report: Datascope Corp. CS100 Intra-Aortic Balloon Pump, Chinese, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3013-45
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b4,g3, g6, h2, h6(type of investigation, investigation findings, investigation conclusions), h11.A getinge field service engineer (fse) evaluated the unit and was able to confirm the reported issue.The fse replaced the video receiver to lcd cable.Product passed all functional and safety tests per manufacturer specifications.The equipment has been delivered to the customer and is ready for clinical use.Based on the available information the effect of display failure on the cs100 is confirmed.The video receiver to lcd cable was replaced to resolve the issue.The defective part was not returned for failure analysis because the spare parts need to be archived.Therefore, a possible cause could not be determined.Fault logs were not provided.

• Brand Name: CS100 Intra-Aortic Balloon Pump, Chinese, 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: 50514669
• Report Number: 2249723-2026-0004049
• Device Sequence Number: 10681265
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: (01)10607567107790
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• 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): 09/11/2026

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• 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: 08/07/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 08/30/2026
• Supplement Report FDA Received Date: 09/17/2026
• 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