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	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2024
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 preventive maintenance (pm) performed by a getinge service territory manager (stm) the cs300 intra-aortic balloon pump (iabp) the display had horizontal lines on the bottom as well as blurry spots.There was no patient involvement reported.
Additional Manufacturer Narrative
The service territory manager (stm) evaluated the unit on a later date.The stm successfully completed a function check with testing catheter and trainer without issue upon initially testing unit.In order to solve the issue, the stm replaced display, display grid/casing, and display cable, and successfully obtained a clear display without issues.The coiled cord, when attempted out of the box, produced electrical test fails code 120.The existing coiled cord was left on unit, fully functional, which would have been replaced as a precaution.Preventative maintenance (pm) was completed successfully with measurements and calibration information separately.The unit was calibrated and passed all functional and safety tests per factory specifications.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h10, h11 corrected fields: d1, d4.
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b4, g3, g6, h2, h6, h11.Corrected fields: d4, h6 (type of investigation, investigation findings, investigation conclusion).The failure analysis and testing dept.Received the following parts associated with this complaint: part number (b)(4) coiled cord serial number (b)(6) part number (b)(4) mounting plate serial number na part number (b)(4) cable to video receiver serial number 20 26_meritec part number (b)(4) display serial number (b)(6) these parts were received with a reported unit failure of the display having horizontal lines on the bottom as well as blurry spots.The failure analysis and testing dept.Performed a visual inspection and found the parts to be in good condition, except part number (b)(4) display serial number (b)(6), that had scratches and marks on it.The failure analysis and testing dept.Installed the parts into the cs300 test fixture and tested the parts to factory specifications per the cs300 service manual.The fat could not verify the failure of horizontal lines on the bottom of the display, and blurry spots after an extended run-time of the cs300.All parts passed testing.Retaining the parts in the fat per procedure.
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).

• 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: arelean guzman ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18608751
• Report Number: 2249723-2024-00375
• Device Sequence Number: 2820947
• Product Code: DSP
• UDI-Device Identifier: 10607567108704
• UDI-Public: (01)10607567108704(21)SI01072-L6
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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,Followup,Followup,Followup
• Report Date (Section B): 10/17/2024

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-3023-53
• Device Catalogue Number: 0998-UC-3023-53
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2024
• Supplement Date Received by Manufacturer: 03/01/2024; 05/02/2024; 09/20/2024; 10/17/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/03/2024; 09/24/2024; 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2007
• 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