MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,NON-UTS,INT'L; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-58
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during use on a patient, the cs300 intra-aortic balloon pump (iabp) units fiber optic does not work.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the cs300 intra-aortic balloon pump (iabp).Fiber optic module works correctly, no failures are shown in the fiber optic performance test.Fse conducted calibration of sensors, functional tests.Equipment suitable for clinical use.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated data: b4,g2, g3, g6, h2, h10, h11.Corrected data: b5, b6, b7, d10, h6 ( impact & clinical code).
Event or Problem Description
It was reported that during a routine check the cs300 intra-aortic balloon pump (iabp) units fiber optic does not work.There was no patient involvement reported.
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).

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, SPANISH,NON-UTS,INT'L
• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 17906708
• Report Number: 2249723-2023-04397
• Device Sequence Number: 20807721
• Product Code: DSP
• UDI-Device Identifier: 10607567108759
• UDI-Public: (01)10607567108759(21)SA04974B6
• 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): 09/22/2024

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-3023-58
• Device Catalogue Number: 0998-UC-3023-58
• 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: 10/03/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 02/01/2024; 09/22/2024
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 12/05/2023; 02/02/2024; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2006
• 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: UNKNOWN.
• Patient Sex: Unknown