MAUDE Adverse Event Report: Datascope Corp. CS300 Intra-Aortic Balloon Pump, Spanish, 220V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3023-58
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a routine check the cs300 intra-aortic balloon pump (iabp) malfunctioned.Optical display not working has been reported.The customer stated the optical sensor was not functional.No patient was involved.No harm was reported.A getinge field service engineer (fse) was dispatched to evaluate the unit.The fse tested the fiber optic function and it worked as expected, the issue with the pump could not be reproduced.The values are correct and pass the test.Equipment is suitable for clinical use.No parts to be replaced or returned.The unit passed all functional and safety tests to manufacturer specifications.
Additional Manufacturer Narrative
E1 - initial reporter: (b)(6).E1 - event site name: (b)(6) hosptital.Upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CS300 Intra-Aortic Balloon Pump, Spanish, 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: 50912777
• Report Number: 2249723-2026-0004443
• Device Sequence Number: 5753043
• Product Code: DSP
• UDI-Device Identifier: 10607567108339
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K112372
• 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): 09/28/2026

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: 0998-00-3023-58
• Device Catalogue Number: 0998-00-3023-58
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Unknown IAB catheter - OT# (b)(4).
• Patient Sex: Unknown