MAUDE Adverse Event Report: Datascope Corp. CS300 Intra-Aortic Balloon Pump, Japanese, 110V; System, Balloon, Intra-Aortic And Control

Model Number	0998-00-3023-65
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by clinical engineer that during use, the cs300 intra-aortic balloon pump (iabp) malfunctioned.Patient involved.No harm reported.Optic sensor not detecting signal has been reported.Upon connecting the iab optical sensor connector, an "iab optical sensor module malfunction" alarm immediately occurred, preventing calibration and arterial pressure measurement using the optical sensor.Checking by unplugging and replugging the connector did not resolve the issue, so the patient was switched to another iabp (cardiosave), where the optical sensor functioned without problems.Fse reported customer about possible fault with optical sensor module, customer decided that repair is not necessary as it would be costly.No onsite work was required.Issue resolved over telephone.The customer canceled the repair.
Additional Manufacturer Narrative
(b)(6) upon completion of the investigation into this event a follow up report will be submitted.

• Brand Name: CS300 Intra-Aortic Balloon Pump, Japanese, 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: 50865374
• Report Number: 2249723-2026-0004398
• Device Sequence Number: 9379620
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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: 0998-00-3023-65
• Device Catalogue Number: 0998-00-3023-65
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2013
• 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: sheath introducer (TERUMO 8fr 10cm)
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 140 LB