MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,NON-UTS,INT'L; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-58
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1 full event site name is (b)(6).A supplemental report will be submitted upon completion of investigation.
Event or Problem Description
It was reported that before use, cs300 intra aortic balloon pump (iabp) screen did not turn on properly.There was no patient involved.
Additional Manufacturer Narrative
It was reported that prior to use, the device the cs300 intra-aortic balloon pump (iabp) screen does not turn on properly.There was no patient involved.A getinge field service engineer (fse) evaluated the unit and found no fault was observed, no error message appeared.Monitored that connections are adjusted and the correct operation of the equipment is checked.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,NON-UTS,INT'L
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21270792
• Report Number: 2249723-2025-0000419
• Device Sequence Number: 3916624
• Product Code: DSP
• UDI-Device Identifier: 10607567108759
• UDI-Public: (01)10607567108759
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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-UC-3023-58
• Device Catalogue Number: 0998-UC-3023-58
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/20/2025
• 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