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	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the cs100 intra-aortic balloon pump (iabp) gave an error: maintenance required, code 9.It is unknown when the malfunction occurred.No patient involved and no harm is reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse reported that they were not able to reproduce the error occurred.As per manual, they removed and replaced the fiber optic module as required.Completed repair successfully.Product passed all functional and safety tests per manufacturer specifications.
Additional Manufacturer Narrative
Cs100 upgraded to cs300.It gets labeled with the stickers showing upgraded with conversion kit.No product details are changed.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: 50749858
• Report Number: 2249723-2026-0004263
• Device Sequence Number: 10221752
• Product Code: DSP
• UDI-Device Identifier: 10607567107394
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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
• Device Model Number: 0998-00-3013-53
• Device Catalogue Number: 0998-00-3013-53
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown