MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-67
Medical Device Problem Code	Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump, italian, 220v intra-aortic balloon pump (iabp) was faulty due to blood invasion.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Other contact person: (b)(6).Other contact phone number: (b)(6).Other contact email: (b)(6) updated field: b4, b5, d9, e1(email), g3, g6, h2, h3, h6(type of investigation, investigation findings, component code, investigation conclusions), h11.Corrected field: e1 event site name.A getinge field service engineer (fse) replaced safety disk, crm module, blood detect and purge valve group.Functional tests performed with positive results.The equipment has been returned to the customer for clinical use.
Event or Problem Description
It was reported by the customer that during use the cs100 intra-aortic balloon pump, italian, 220v was faulty due to blood invasion.No harm or injury to the patient was reported.
Additional Manufacturer Narrative
Other contact email: (b)(6).Corrected fields: h6(investigation findings, component codes, investigation conclusions) updated fields: b4, g3, g6, h2, h11.
Event or Problem Description
N/a.

• Brand Name: CS100 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: 23848396
• Report Number: 2249723-2025-0005181
• Device Sequence Number: 18541607
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 01/30/2026; 03/02/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 02/15/2026; 03/04/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown