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

Model Number	0998-00-3013-69
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) has not reading pressure parameter.No patient harm/injury reported.
Additional Manufacturer Narrative
Due to character restrictions in block e1.(b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) wasn¿t reading the pressure curves by the monitor.No patient harm/injury reported.
Additional Manufacturer Narrative
Due to character limitation, below field are added from e1- event site name : (b)(6).Updated fields : b4, b5, d9, e1 (event site name), g3, g6, h2,h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, investigation conclusions).Corrected fields: e1 (event site telephone).A getinge field service engineer (fse) evaluated the unit and verified that the p10 pin was giving a poor contact in the connections.The pin was removed, cleaned, and all debris inside the pin was removed, then it was reinstalled.Tests were carried out with a pressure transducer and signals from both the monitor and the cs100 were passing correctly.All service mode tests were also performed and are in accordance with the manual.The safety disc, which had expired due to hours of use, was replaced.The equipment has been cleared for use.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, PORTUGUESE, 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: ewelina chorlowska ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 23004170
• Report Number: 2249723-2025-0003770
• Device Sequence Number: 8833481
• Product Code: DSP
• UDI-Device Identifier: 10607567107769
• UDI-Public: (01)10607567107769
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 11/24/2025

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: 0998-00-3013-69
• Device Catalogue Number: 0998-00-3013-69
• 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: 08/19/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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