MAUDE Adverse Event Report: Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3013-55
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a routine check the cs100 intra-aortic balloon pump (iabp) had an external helium leak from the cylinder.No patient was involved.No harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.It was reported that helium gas manifold washer was damaged.The washer was replaced from the customer's available stock.After replacing the washer, fse connected the helium gas supply to the system and carried out all necessary safety checks.All safety parameters were found ok, and the valve leakage test was also completed successfully.The system was then checked with patient support, and everything was found working properly.After confirming normal operation, the system was handed over to the department in good working condition.No parts for return reported.No fault logs are available.
Additional Manufacturer Narrative
E1: event site name: (b)(6).Based on the fse's investigation, the helium leak was confirmed to be caused by a damaged helium gas manifold washer.The washer was replaced using the customer's available stock.Following replacement, all necessary safety checks and the valve leakage test were successfully completed.The system was checked with patient support and returned to the department in good working condition.The most probable cause was component reliability.This issue continues to be monitored within the manufacturer¿s quality system.

• Brand Name: CS100 Intra-Aortic Balloon Pump, English, 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: 50928496
• Report Number: 2249723-2026-0004464
• Device Sequence Number: 10759644
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: Other
• Device Model Number: 0998-00-3013-55
• Device Catalogue Number: 0998-00-3013-55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown