MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-65
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, d9, e3, g3, h2, h3, h6 (investigation findings, type of investigation, investigation conclusion), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse performed the operation check."optical sensor calibration was not possible and ap parameters were not displayed." the error was not reproducible.The optical sensor receiving part was cleaned.After each operation, we performed an operation check based on the inspection record sheet and confirmed that it is currently in good condition and working.
Additional Manufacturer Narrative
H11 - a supplemental report will be submitted upon completion of our investigation.Due to character restrictions in block e1: event site name: (b)(6).Event site city:(b)(6).Event site telephone: (b)(6).
Event or Problem Description
It was reported immediately after the start of clinical use that cs100 intra-aortic balloon pump said optical sensor calibration not possible.No harm or injury reported.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, JAPANESE, 110V
• 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: 21505464
• Report Number: 2249723-2025-0000964
• Device Sequence Number: 7974161
• Product Code: DSP
• UDI-Device Identifier: 10607567107684
• UDI-Public: (01)10607567107684
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031636
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 0998-00-3013-65
• Device Catalogue Number: 0998-00-3013-65
• 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: 02/12/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2010
• 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: UNKNOWN.
• Patient Sex: Unknown