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 Codes	Inability to Auto-Fill (1044); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during use the cs100 intra aortic balloon pump experienced an autofill failure and check iab catheter alarm.There was patient involvement; however, no harm or adverse event was reported.
Additional Manufacturer Narrative
Updated fields: b4, b5, d10, g3, g6, g7, h2, h6 (medical device problem code, type of investigation, investigation findings, component code, investigation conclusion), h11 corrected fields: g2 reverted the contents of section a1 (patient id), e1 (event site postal code), h4 (manufacture date) to blank.A getinge field service engineer (fse) evaluated the device and identified pressure performance below specification, a damaged positive pressure pump shaft, and recommended replacement of the positive and negative pressure pumps.However, the recommended repair was not performed because the customer had not obtained the required purchase order (po) approval.

• 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: 50221282
• Report Number: 2249723-2026-0003816
• Device Sequence Number: 10564145
• Product Code: DSP
• UDI-Device Identifier: 10607567107295
• UDI-Public: (01)10607567107295
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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: 0998-00-3013-55
• 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: 07/22/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 08/12/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Balloon Catheter
• Patient Sex: Unknown