MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, PORTUGUESE,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-68
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by getinge field service engineer that during preventive maintenance of cs300 intra aortic balloon pump, it was found that the batteries were not within the parameters recommended by the manufacturer.There was no patient involvement and no injury.
Additional Manufacturer Narrative
A supplemental report will be submitted upon the completion of investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: d1 (brand name), d4 (version or catalog #, unique identifier (udi) #).
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected fields: h6 (component codes, health effect ¿ impact codes).To solve the issue, the field service engineer replaced the two units of batteries (0146-00-0039).All functional and safety tests were performed and were met to the factory specifications.

• Brand Name: CS300 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: 23697971
• Report Number: 2249723-2025-0004914
• Device Sequence Number: 13319877
• Product Code: DSP
• UDI-Device Identifier: 10607567108827
• UDI-Public: (01)10607567108827
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/09/2026

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: Other
• Device Model Number: 0998-UC-3023-68
• Device Catalogue Number: 0998-UC-3023-68
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2025
• Supplement Date Received by Manufacturer: 01/02/2026; 01/09/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 01/09/2026; 01/09/2026
• 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