MAUDE Adverse Event Report: DATASCOPE CORP. - MAHWAH CS300; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	N/A
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer requested getinge to evaluate the iabp and a quote for the service was submitted in connection with this event.No service order report available yet.A supplemental report will be submitted when this information is provided to us.
Event or Problem Description
It was reported that during daily check, the cs300 intra-aortic balloon pump (iabp) was not displaying the characters correctly.There was no patient involvement, and no adverse event reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis of production: (3331/213) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis: (4109/213) the review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.Trend analysis: (4110/213) the overall 24 month product complaint trend data for the period (apr 2019 through mar 2021) was reviewed.There were no triggers identified for the review period.
Event or Problem Description
It was reported by the customer that during daily check, the cs300 intra-aortic balloon pump (iabp) was not displaying the characters correctly.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp unit and was able to verified the issue.The fse replaced the assy,dsply controller pcb and the cable coiled, iabp to resolve the problem.After replacement, the fse then performed and completed a full calibration, functional and safety checks to meet factory specifications.Unit passed all.The iabp was then released to the customer and cleared for clinical service.

• Brand Name: CS300
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ
• MDR Report Key: 11574013
• Report Number: 2249723-2021-00630
• Device Sequence Number: 3460459
• Product Code: DSP
• UDI-Device Identifier: 10607567108254
• UDI-Public: 10607567108254
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2021

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: N/A
• Device Catalogue Number: 0998-00-3023-57
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/04/2021
• Supplement Date Received by Manufacturer: 03/26/2021; 06/24/2021
• Initial Report FDA Received Date: 03/26/2021
• Supplement Report FDA Received Date: 04/16/2021; 06/24/2021
• Patient Sequence Number: 1