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	No Display/Image (1183); Output below Specifications (3004); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to character limitation in e1 for event site name, the full event site name is (b)(6) hospital.Due to character limitation in e1 for event site address, the full event site address is (b)(6).Due to character limitation in e1 for event site telephone, the full event site telephone is (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) unit is having issue with on/off switch, which is causing machine to shutdown.No patient harm or injury reported.
Event or Problem Description
It was reported that the cs100 intra-aortic balloon pump (iabp) unit is experiencing an issue with the on/off switch, which is causing the machine to shut down.The issue was also identified during the service inspection, where the technician confirmed that the on/off switch was faulty.No patient involved.
Additional Manufacturer Narrative
Updated fields:b4,b5,d9,g3,g6,h2,h3,h11.It was reported by customer that during daily inspection, the cs100 (iapb) had issue with on/off switch, which is causing machine to shutdown.There was no patient involved.Technician confirmed display failure (the screen was shaking, making it impossible to view the parameters on the screen).Technician reported: "there was no problem with the power switch, only with the screen of the device, which was resolved by cleaning the inside of the board and connections." an opening was made in the screen cover and an internal cleaning was done with contact cleaner to remove bad contacts.After cleaning, the equipment remained in operation for 2 hours and did not present any abnormality in its operation.The safety disc was replaced due to expired usage time.No other parts were replaced.The device passed all functional and safety tests according to factory specifications.The device was given to customer and cleared for customer 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: 24311407
• Report Number: 2249723-2026-0001184
• Device Sequence Number: 5583467
• 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): 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: 0998-00-3013-69
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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