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	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiosave intra aortic balloon pump (iabp) optical sensor was inserted loosely.When the optical sensor was inserted into the fiber optic module for use in treatment, it was found to be loose.As a result, the device was replaced with another iabp and treatment was started.A plastic foreign object was found at the receiving side of the fiber optic module.There was no patient harm or injury reported.
Additional Manufacturer Narrative
Due to character restrictions in block e1 full event site name is: (b)(6), full event site address is (b)(6), full event site city name is (b)(6).A supplemental report will be submitted upon completion of investigation.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h3, h6 (health effect ¿ clinical code, type of investigation, investigation findings, investigation conclusions), h11.The getinge field service engineer (fse) inspected the device and found that the fiber optic module was not responding.A piece of plastic/unknown foreign material (not a getinge product) was discovered inside the fiber optic module.After the foreign material was removed, the module responded normally, passed testing, and the insertion issue was resolved.There was no reported patient harm.All operational and safety checks were performed.
Event or Problem Description
It was reported that when inserting the fiber optic module for use in treatment, the cs300 intra aortic balloon pump (iabp) had a loose optical sensor connection when the optical sensor was inserted into the fiber optic module for treatment.As a result, the device was replaced with another iabp and treatment was started.There was no reported patient harm.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h11.Corrected fields: b5.

• 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: 23424612
• Report Number: 2249723-2025-0004484
• Device Sequence Number: 8253602
• 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): 12/21/2025

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: 11/21/2025; 12/21/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/01/2025; 12/21/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown