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

Model Number	0998-00-3023-61
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
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 daily inspection, cs300 intra-aortic balloon pump (iabp) required optics sensor calibration.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, b5, g3, g6, h2, h6(health effect ¿ clinical code, health effect ¿ impact codes), h11.
Event or Problem Description
It was reported during tratament that cs300 intra-aortic balloon pump (iabp) required optics sensor calibration.
Additional Manufacturer Narrative
Updated field: b4, d9, g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, health effect ¿ impact codes, investigation conclusions), h11.A getinge field service engineer (fse) stated there isn't any problem with the unit.Fse informed the customer the procedure to calibrate the iabp optical sensor.The iabp works normal.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated field: b4, g3, g6, h2, h11.Corrected fields: h6 (health effect ¿ clinical code, health effect ¿ impact codes).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, GERMAN, 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: 21292379
• Report Number: 2249723-2025-0000492
• Device Sequence Number: 15397421
• Product Code: DSP
• UDI-Device Identifier: 10607567108278
• UDI-Public: (01)10607567108278
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2025

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: 0998-00-3023-61
• Device Catalogue Number: 0998-00-3023-61
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 04/14/2025; 05/09/2025; 05/19/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 05/08/2025; 05/14/2025; 05/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2010
• 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: N/A.
• Patient Sex: Unknown