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

Model Number	0998-UC-3023-61
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) unit has slow gas loss alarm.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Leak tests are carried out.The equipment does not leak.It is noted that the error message reported was due to that alarm had been deactivated of slow gas loss alarm and the equipment was warning that this alarm was inoperative.The correct operation of the equipment is verified.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
H6 (clinical and impact code).
Event or Problem Description
It was reported that before use, the cs300 intra-aortic balloon pump (iabp) unit has slow gas loss alarm.The alarm was deactivated and the iabp was not used.There was no patient involved.
Additional Manufacturer Narrative
Udi related data quality updates only.Providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, GERMAN,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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 19756146
• Report Number: 2249723-2024-02855
• Device Sequence Number: 18396229
• Product Code: DSP
• UDI-Device Identifier: 10607567108773
• UDI-Public: (01)10607567108773(21)SI151245A9
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/20/2025

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-3023-61
• Device Catalogue Number: 0998-UC-3023-61
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2024
• Supplement Date Received by Manufacturer: 07/30/2024; 08/06/2024; 02/20/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/02/2024; 08/06/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown