MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-68
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported before use that the cs300 intra-aortic balloon pump (iabp) had unknown fault code error.No patient was involved.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h3, h6 (type of investigation, component code investigation findings, investigation conclusion), h11.Corrected field: d1.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse replaced the manifold, drive and pcb,iabp main board to resolve the issue.Equipment suitable for clinical use.Based on the evaluation results provided by the field service engineer, the failure occurred due to a defective ¿manifold drive and pcb,iabp main board.The issue was resolved by replacing the malfunctioning part.However, root cause evaluation for the replaced part cannot be performed since the defective part was (discarded, cannot be returned due to customer policy, etc).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21582455
• Report Number: 2249723-2025-0001181
• Device Sequence Number: 9275642
• Product Code: DSP
• UDI-Device Identifier: 10607567108353
• UDI-Public: (01)10607567108353
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2025

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: 0998-00-3023-68
• Device Catalogue Number: 0998-00-3023-68
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/04/2025
• 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