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	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that during a scheduled inspection the cs300 intra-aortic balloon pump (iabp) malfunctioned.System malfunction fault 45 occured.No patient involved and no harm is reported.It was reported that customer stated that repairs will not be performed as the equipment will be updated, and no verification is necessary.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Event site name: (b)(6).Upon completion of the investigation into this event a follow up report will be submitted.
Additional Manufacturer Narrative
Additional phone number: (b)(6).Updated fields: b1, b4, d10, g3, g6, g7, h2, h6 (type of investigation, investigation findings, component code, investigation conclusion), h11.Corrected fields: a1 need revert to blank, e2, e3, g2, h4 need revert to blank.Fse states a response from clinical engineer stated that repairs will not be performed as the equipment will be updated and no verification is necessary.Therefore, please close this matter.No service reported or fault logs were provided.

• 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: 50799197
• Report Number: 2249723-2026-0004332
• Device Sequence Number: 16099591
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2008
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown