MAUDE Adverse Event Report: DATASCOPE CORP. CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3023-53
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during preventative maintenance by getinge field service engineer, the cs300 intra-aortic balloon pump (iabp) unit has a distorted display.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields: b4, d8, d9, g1 (contact person ¿ mfg site), g3, g6, h2, h3, h6 (type of investigation, investigation findings, component codes, investigation conclusions), h11.Corrected field: h8.A getinge field service engineer (fse) replaced display cable which resolved the issue.Unit passed all calibration, functional and safety tests performed.Unit was returned to customer and cleared for clinical use.The failure analysis and testing dept.Received part display cable with a reported unit failure of a distorted display.The failure analysis and testing dept.Performed a visual inspection and found the part to be in good condition.The failure analysis and testing dept.Installed display cable into the cs300 test fixture and tested the cable to factory specifications per the procedure.After one hour of run time, the fat could not replicate the complaint of a distorted display.The display cable passed testing.Retaining the cable in the fat per procedure.
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM
• 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: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 20480384
• Report Number: 2249723-2024-0004272
• Device Sequence Number: 12803396
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: (01)10607567108704
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: Other
• Device Model Number: 0998-UC-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 05/22/2025
• 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