MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, PORTUGUESE,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-69
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1, for event site name & event site address, event site name - (b)(6), event site address - (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during routine testing the cs100 intra-aortic balloon pump (iabp) was showing "system failure" error.There was no patient involvement.
Additional Manufacturer Narrative
Due to character limitation in e1 for event site phone and event site address: (b)(6).Updated fields - b4, d9, g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected field - d4(unique identifier (udi), e1 (event site phone, event site address), h6 (medical device ¿ problem code).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, equipment checked, and it showed a constant alarm when turned on, the motor was started, but at a certain moment it stops and shows system failure immediately on the screen.In service mode, errors 45 and 54 are identified by the system.Therefore, following the guidelines provided by the factory and the service manual, two boards are requested to correct the error, solenoid driver board (0670-00-0639) and main board (0670-00-0788), the same will be requested to repair the present error.No repair information available.In future if we receive any repair information will reopen and update the investigation.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, PORTUGUESE,NON-UTS,INTL
• 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: 21984049
• Report Number: 2249723-2025-0002140
• Device Sequence Number: 15573302
• Product Code: DSP
• UDI-Device Identifier: 10607567112596
• UDI-Public: (01)10607567112596
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 12/04/2025

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-3013-69
• Device Catalogue Number: 0998-UC-3013-69
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2025
• Supplement Date Received by Manufacturer: 12/02/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 12/04/2025
• 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