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

Model Number	0998-00-3013-64
Medical Device Problem Codes	Battery Problem (2885); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during routine check by customer the cs100 had message about a security disk leak and battery maintenance to be performed.No patient was involved.
Additional Manufacturer Narrative
Another contact info: (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4,g3,g6,h2,h6(type of medical device problem code,investigation,investigation findings and investigation conclusions).The fse stated that this is an error, and they appeared due to pm being a month overdue.Fse completed maintenance and validation successfully.Product passed all functional and safety tests per manufacturer specifications.The device which required pm was a cs100 upgraded to cs300.
Additional Manufacturer Narrative
Updated fields: b4,g3,g6,h2,h11.It is currently a cs300.It might have been a cs100 in the past that was upgraded to a cs300.Fse stated that he don¿t know the history of machines.He only known it for three years, since he joined getinge.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, FRENCH, 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: 24739860
• Report Number: 2249723-2026-0001936
• Device Sequence Number: 13324149
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: (01)10607567107509
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 05/15/2026

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: 0998-00-3013-64
• Device Catalogue Number: 0998-00-3013-64
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 04/30/2026; 05/14/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/11/2026; 05/16/2026
• 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