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 Codes	No Device Output (1435); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated fields - b4, e1(contact person name), g3, g6, h2, h6 (type of investigation, investigation findings, investigation conclusions), h11.Corrected code-h6 (medical device problem).A getinge field service engineer (fse) was dispatched to evaluate the unit.Fse states, after visiting the hospital and inspecting the device, fse confirmed that the symptoms were recurring.The cause is strongly suspected to be a failure of the fiber optic module.To resolve the issue, the above part must be replaced.Pumping is possible without the optical sensor, but it is recommended that you discontinue use.Please consider repair or discontinuing use.The customer seems to have decided against repairing it because the cost was too high.No repair information available.In future if we receive any repair information will reopen and update the investigation.
Additional Manufacturer Narrative
Due to character limitation of e1 (event site name and address): (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported by customer that before use the cs300 intra-aortic balloon pump (iabp) had arterial pressure optical sensor module failure.There was no patient involvement.
Additional Manufacturer Narrative
Updated field : b4 , g3 , g6 , h2 , h11.Corrected field : e1 ( initial reporter ) additional reporter name is added in e1 section.
Event or Problem Description
N/a.

• 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: 23433389
• Report Number: 2249723-2025-0004487
• Device Sequence Number: 8672545
• Product Code: DSP
• UDI-Device Identifier: 10607567108322
• UDI-Public: (01)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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 11/20/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/20/2025; 11/20/2025
• 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
• Patient Sex: Unknown