MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3023-83
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the batteries of cs300 intra-aortic balloon pump (iabp) did not last for pm.There was no patient involvement.
Additional Manufacturer Narrative
Due to character limitation in e1 for initial reporter, the initial reporter full name: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields - b3, b4, g3, g6, h2, h11.A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h3,h6 (component code, investigation findings , investigation conclusion, type of investigation)h11.A getinge field service engineer (fse) replaced main batteries (d146-00-0039) because they did not last for the pm.The batteries only lasted 90 minutes.They were due to be replaced on the next pm ((b)(6) 2025).Unit passed all functional and safety tests.Unit cleared for clinical use.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP - UTS, ENGLISH, 110V
• 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: 22122679
• Report Number: 2249723-2025-0002424
• Device Sequence Number: 7062516
• Product Code: DSP
• UDI-Device Identifier: 10607567108285
• UDI-Public: (01)10607567108285
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/04/2025

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: Other
• Device Model Number: 0998-00-3023-83
• Device Catalogue Number: 0998-00-3023-83
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Supplement Date Received by Manufacturer: 06/05/2025; 06/30/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/09/2025; 07/03/2025
• 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