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	Electrical /Electronic Property Problem (1198); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer, during routine check cs100 intra-aortic balloon pump (iabp) had electrical test fails code #50.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: e1 (initial reporter).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6(medical device ¿ problem code, type of investigation, investigation findings, component codes, investigation conclusions).A getinge field service engineer (fse) evaluated the unit and could not duplicate the reported issue, but found the motor control board to be defective.The fse replaced the motor control board and performed test.All functional and safety test performed.Unit was returned to the customer for use.

• 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: 22684412
• Report Number: 2249723-2025-0003307
• Device Sequence Number: 15868891
• Product Code: DSP
• UDI-Device Identifier: 10607567107875
• UDI-Public: (01)10607567107875
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/16/2025

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-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: 07/21/2025
• Supplement Date Received by Manufacturer: 10/06/2025; 10/16/2025
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 10/15/2025; 10/16/2025
• 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
• Patient Sex: Unknown