MAUDE Adverse Event Report: Datascope Corp. CS100 Intra-Aortic Balloon Pump, English, 110V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3013-53
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that prior to use, the cs100 intra-aortic balloon pump (iabp) malfunctioned.Unit experienced a system failure during autofill.There was no patient involved.Device was tested by biomed, and fault was not reproducible.Biomed performed full testing and everything is passing.The fse provided customer the recommended parts to order as precaution.The customer has ordered the recommended parts and will perform the repair.
Additional Manufacturer Narrative
E1.Event site postal code (b)(6).Upon completion of the investigation into this event, a follow up report will be submitted.

• Brand Name: CS100 Intra-Aortic Balloon Pump, English, 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: 50493877
• Report Number: 2249723-2026-0004030
• Device Sequence Number: 10224298
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• UDI-Public: (01)10607567107394
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 08/27/2026

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: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/28/2026
• 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