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 Codes	Decrease in Pressure (1490); Suction Problem (2170); Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the cs100 intra-aortic balloon pump(iabp) when turning on the device, it first started reporting low vacuum and then electrical error code #50.There was no patient involvement.
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: e1 (event site address, event site city), h6 (medical device problem code, investigation findings).
Additional Manufacturer Narrative
Updated fields- b4, g3, g6, h1, h2, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.A getinge field service engineer (fse) was dispatched to evaluate the unit.The (fse) reported that the probable cause of the defect was a compressor defect.The fse replaced the compressor using the customer's discarded cs300 device's compressor was used to resolve the errors.Functional check and test run of the device according to the valid service manual.Functional check were performed according to the manufacturer's recommendations.

• 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: 23777297
• Report Number: 2249723-2025-0005034
• Device Sequence Number: 10117377
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: (01)10607567107875
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 04/09/2026

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: 11/18/2025
• Supplement Date Received by Manufacturer: 03/28/2026; 04/09/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 03/30/2026; 04/09/2026
• 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