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

Model Number	0998-00-3013-45
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Additional phone number:(b)(6) updated fields: b4, d10, g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusion), h11 corrected fields: e2, e3, g2, a1 need revert to blank, h4 need revert to balnk a getinge field service engineer (fse) evaluated the unit and replaced the battery then performed testing.All functional and safety test were performed and passed.No fault logs were provided however a photo of the battery was attached for viewing.Based on the reported battery short run time the failure mode was confirmed.

• Brand Name: CS100 Intra-Aortic Balloon Pump, Chinese, 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: 50645193
• Report Number: 2249723-2026-0004154
• Device Sequence Number: 15967214
• Product Code: DSP
• UDI-Device Identifier: 10607567107790
• UDI-Public: (01)10607567107790
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2026

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: 0998-00-3013-45
• Device Catalogue Number: 0998-00-3013-45
• 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: 08/17/2026
• Supplement Date Received by Manufacturer: 09/17/2026
• Initial Report FDA Received Date: 09/07/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown