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	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.Due to character limitation in block e1: initial reporter: (b)(6), event site name: (b)(6).
Event or Problem Description
It was reported by getinge fst during preventive maintenance that cardiosave intra-aortic balloon pump (iabp) batteries worn out in 3 years less.No patient was involved.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields: b4, g1, g3, g6, h2, h3, h6 (component code, investigation findings , investigation conclusion, type of investigation), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The battery autonomy test failed at 111 minutes.The repair ot was created because the batteries are still within the 3-year validity period.The fse replaced the batteries to resolve the issue.
Event or Problem Description
Na.
Additional Manufacturer Narrative
Updated fields - b4, g3, g6, h2, h3, h6 (health effect ¿ clinical code), h11 corrected field - e1(initial reporter, event site email), e2(health professional), e3(occupation), e4(initial report sent to fda), g2(report source).

• 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 21512127
• Report Number: 2249723-2025-0000977
• Device Sequence Number: 15455541
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/10/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 09/19/2025; 10/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown