MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-55
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during routine check, the cs100 intra-aortic balloon pump (iabp) screen doesn't turn on and screen went black due to that screen couldn't be seen.There was no patient involved and no harm or injury reported.
Additional Manufacturer Narrative
Due to character restriction in block e1: event site name, address, and city: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Corrected fields : e1 ( event site city).Updated fields: b4, g3, g6, h2, h6(investigation findings, type of investigation, investigation conclusions), h11.A getinge field service engineer checked the machine and found that the screen ribbon cable had a problem.Initially, the problem was fixed by cleaning the ribbon cable connector and plugging it back in tightly.The machine could be turned on and the screen could be seen as usual.Test run the machine and it worked normally.Note: it was recommended that the hospital replace the ribbon cable as this symptom may reoccur.Provide a quotation for a new ribbon cable to the hospital later.
Additional Manufacturer Narrative
Due to characterization limit e1 event site name: (b)(6).Updated fields: b4, e1(event site name), g3, g6, h2, h6(investigation findings, component codes, investigation conclusions).A getinge field service engineer checked the machine and found that the screen ribbon cable had a problem.Initially, the problem was fixed by cleaning the ribbon cable connector and plugging it back in tightly.The machine could be turned on and the screen could be seen as usual.Test run the machine and it worked normally.Note: it was recommended that the hospital replace the ribbon cable as this symptom may reoccur.Provide a quotation for a new ribbon cable to the hospital later.Fse replaced the display to video receiver cable.Tested the device; it was working normally.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,INTL
• 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: 22685395
• Report Number: 2249723-2025-0003316
• Device Sequence Number: 21055849
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: (01)10607567107875
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 02/25/2026

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-UC-3013-55
• Device Catalogue Number: 0998-UC-3013-55
• 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: 07/20/2025
• Supplement Date Received by Manufacturer: 08/13/2025; 02/13/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/20/2025; 02/26/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown