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); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during daily cleaning, cs100 intra-aortic balloon pump (iabp) has display failure.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: due to characterization limit e1 (event site name:(b)(6) hospital) event site address: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, b5, d9 (device available for eval?), g3, g6, h2, h3, h6 (type of investigation, investigation findings, investigation conclusion), h11.Corrected fields: d4 (version #), e1 (event site telephone), h6 (medical device ¿ problem code).Due to characterization limit e1 (event site name): (b)(6) hospital.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that the issue was solved by reconnecting the screen cable.The unit passed all the functional and safety tests as per factory specifications.It was released to the customer for use.
Event or Problem Description
It was reported that during daily cleaning, the customer noticed that the cs100 intra-aortic balloon pump (iabp) display had a stripe on the screen.There was no patient involvement reported.

• 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: 23531746
• Report Number: 2249723-2025-0004678
• Device Sequence Number: 9021336
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2026

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: 10/22/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 01/02/2026
• 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