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 Codes	Display or Visual Feedback Problem (1184); Image Display Error/Artifact (1304)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions, event site name: (b)(6) hospital.A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) screen was changing the display characters.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d10, g1(contact person ¿ mfg site), g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, component codes, health effect ¿ impact codes, investigation conclusions), h11.A getinge field service engineer (fse) evaluated the unit and replaced the display screen which was supplied by the customer used from another unit.There were no failures in the logs due to interference issue, but the device still worked despite this.All functional and safety checks have been performed to meet factory specifications.The unit was returned to the customer.
Event or Problem Description
It was reported that cs100 intra-aortic balloon pump (iabp) screen was changing the display characters.There was no patient involvement.
Additional Manufacturer Narrative
Corrected field : h6 ( medical device ¿ problem code ).Updated field : b4 , g3 , g6 , h2, h11.
Event or Problem Description
N/a.

• 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: 22305844
• Report Number: 2249723-2025-0002690
• Device Sequence Number: 12761828
• 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,Followup
• Report Date (Section B): 10/23/2025

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: 06/09/2025
• Supplement Date Received by Manufacturer: 10/16/2025; 10/23/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 10/23/2025; 10/23/2025
• 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
• Patient Sex: Unknown