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

Model Number	0998-00-3023-64
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon the completion of investigation.
Event or Problem Description
It was reported that cs300 intra aortic balloon pump had a speaker problem.The patient involvement is unknown.
Event or Problem Description
It was reported that cs300 intra aortic balloon pump had a speaker problem.There was no patient involvement and no injury as the reported event occured during preventive maintenance.
Additional Manufacturer Narrative
Due to character limit in the e1 section the full initial reporter's name is (b)(6).Updated fields: b4, b5, b6, b7, d5, d8, d10, e1- initial reporter name, event site email address, e2, e3, g1- contact person-mfg site, g3, g6, h2, h3, h6-(type of investigation code, investigation findings code, investigation conclusion code, health effect -clinical code, health effect-clinical impact code, h11.Despite good faith efforts (gfes), no response has been received for information regarding the reported malfunction.If any pertinent information is received in the future, the complaint will be reopened and updated accordingly.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 21122115
• Report Number: 2249723-2025-0000146
• Device Sequence Number: 8760472
• Product Code: DSP
• UDI-Device Identifier: 10607567108308
• UDI-Public: (01)10607567108308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/17/2025

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: 0998-00-3023-64
• Device Catalogue Number: 0998-00-3023-64
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2004
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown