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

Model Number	0998-UC-3023-65
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that  the cs300 intra-aortic balloon pump (iabp) had a malfunction of the arterial pressure  connector.They received a message saying that the connection was unstable and it could not be used normally.The arterial pressure cable connector was re-connected to the pressure input of the iabp and the issue was resolved.Iabp therapy was continued with this iabp unit without any further issues.There was no reported injury or harm.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate the issue.The fse could not reproduce the issue.No repair of the unit was necessary.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Providing updated device identification information in alignment with gudid.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• 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: 19482624
• Report Number: 2249723-2024-02376
• Device Sequence Number: 15537681
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: (01)10607567108803(21)SI164747I9
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2025

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-UC-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• 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: 05/20/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 02/13/2025
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 06/25/2024; 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown