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	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 during routine check that a cs300 intra-aortic balloon pump (iabp) was not detecting arterial blood pressure.No patient involved.
Event or Problem Description
It was reported during routine check by customer that a cs300 intra-aortic balloon pump (iabp) was not detecting arterial blood pressure.Ecg cable was damaged.No patient involved.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional information: e1(email) - (b)(6).Updated fields: b4, g1, g3, g6, h2, h6, h11.Corrected fields: h6(type of investigation).
Additional Manufacturer Narrative
Due to characterization limit e1 initial reporter: (b)(6).Updated fields: b4, d9, e1(initial reporter), e3, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected field: b5.A getinge field service engineer (fse) ran the checks, and the machine correctly detected the ecg signal and blood pressure with the trainer.However, the ecg cable was damaged.Ecg cable was replaced and retained by the customer, as the ecg cable was purchased directly by him.Repair completed.Functional tests performed with positive results.The equipment was returned to the customer for clinical use.

• 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: 24232917
• Report Number: 2249723-2026-0001028
• Device Sequence Number: 10188496
• Product Code: DSP
• UDI-Device Identifier: 10607567112619
• UDI-Public: (01)10607567112619
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2026

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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/19/2026; 03/13/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 03/05/2026; 03/13/2026
• 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: N/A.
• Patient Sex: Unknown