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

Model Number	0998-UC-3023-65
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
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 daily inspection, the cs300 intra-aortic balloon pump (iabp) unit screen display failed.There was no patient involvement.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The getinge field service engineer (fse) replaced the video receiver board and display cable.Operational inspection was performed based on inspection records.The unit is in good condition.
Event or Problem Description
It was reported that during daily inspection performed by getinge field service engineer (fse), the cs300 intra-aortic balloon pump (iabp) unit screen display failed.There was no patient involvement.
Additional Manufacturer Narrative
Due to character restrictions in block e1 event site name : (b)(6).Due to character restrictions in block e1 city : (b)(6).
Event or Problem Description
N/a.
Additional Manufacturer Narrative
The following investigation was performed by technician of the maquet failure analysis and testing dept.(fat) wayne, nj.The failure analysis and testing dept.Received the following parts associated with this complaint: pcb, color video receiver serial number (b)(6).Cable, video receiver to lcd 08 30_meritec.These parts were received with a reported unit failure of screen display failure.The failure analysis and testing dept.Installed the parts into the cs300 test fixture and tested parts to factory specifications per the cs300 service manual.After an extended run-time the fat could not duplicate the reported complaint by the customer.Pcb, color video receiver serial number (b)(6) and cable, video receiver to lcd 08 30_meritec passed testing.The non-conformances with the returned components were not identified.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
Event or Problem Description
N/a.

• Brand Name: CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18357080
• Report Number: 2249723-2023-05346
• Device Sequence Number: 6924429
• Product Code: DSP
• UDI-Device Identifier: 10607567108803
• UDI-Public: (01)10607567108803(21)SI156052C9
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/02/2024

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-3023-65
• Device Catalogue Number: 0998-UC-3023-65
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 12/24/2023; 01/09/2024; 02/05/2024; 08/07/2024; 10/02/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 01/03/2024; 02/01/2024; 02/05/2024; 08/22/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2009
• 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: N/A.
• Patient Sex: Unknown