MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-00-3013-67
Medical Device Problem Code	Display Difficult to Read (1181)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character restrictions in block e1, event site name: (b)(6).Event site address: (b)(6).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) display was vibrating and was unreadable.No harm/ adverse event was reported.
Event or Problem Description
It was reported that before use, the cs100 intra-aortic balloon pump (iabp) display was vibrating and was unreadable.However, there was no patient involved.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d9 (device available for eval), d10, g1, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, health effect - impact codes, investigation conclusions), h11.A getinge field service engineer (fse) evaluated the iabp unit and was able to reproduce the reported issue.To fix the issue, the fse cleaned the video card contacts and replaced the coiled cable and performed all functional and safety checks to meet factory specifications.Unit passed all functional and safety test per factory specifications.The iabp was then released and cleared for clinical service.
Additional Manufacturer Narrative
Updated fields: b4, b5, b6, b7, d9, d10, e2, g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusion, impact codes), h11.A getinge field service engineer checked the machine, defect was eliminated by cleaning the video card contacts and replacing the monitor's spiral cable.Operational tests performed successfully.Repair completed, the equipment can be used.
Event or Problem Description
It was reported that before use, cs100 intra-aortic balloon pump (iabp) display was vibrating and was unreadable.There was no patient involved.
Additional Manufacturer Narrative
Updated fields: kindly disregard the previous mdr (2249723-2025-0002931) follow up 1 as it was submitted in error.A supplemental report will be submitted upon completion of our investigation and additional information.
Event or Problem Description
N/a.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V
• 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: 22456327
• Report Number: 2249723-2025-0002931
• Device Sequence Number: 8383625
• Product Code: DSP
• UDI-Device Identifier: 10607567107486
• UDI-Public: (01)10607567107486
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/18/2025

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: 0998-00-3013-67
• Device Catalogue Number: 0998-00-3013-67
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/01/2025; 08/11/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 07/22/2025; 08/07/2025; 08/18/2025
• 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