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

Model Number	0998-00-3013-55
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4, g3, g6, h2, h11, d5, e2, g2, h6 (type of investigation, investigation findings, investigation conclusions) a getinge field service engineer (fse) evaluated the device and identified a damaged ecg lead.A replacement lead was determined to be required, and a quotation was prepared for the customer.¿the unit was evaluated by service, and the defective component (ecg lead) was identified.The reported failure aligns with a known failure mode.Repair/service is pending due to part availability.The investigation is closed based on the current information and will be reopened if new details become available.

• Brand Name: CS100 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: 50219205
• Report Number: 2249723-2026-0003813
• Device Sequence Number: 10584685
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: (01)10607567107295
• 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): 09/29/2026

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: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/29/2026
• 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