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

Model Number	0998-00-3013-64
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to evaluate this unit.The fse was unable to duplicate the issue.The fse completed all safety, functionality and calibration checks and all tests passed to factory specifications.
Event or Problem Description
It was reported that during a self-test, the display of the cs300 intra-aortic balloon pump (iabp) was unreadable.There was no patient involvement, and no adverse event reported.
Event or Problem Description
It was reported that during a self-test, the display of the cs300 intra-aortic balloon pump (iabp) was unreadable.There was no patient involvement, and no adverse event reported.
Additional Manufacturer Narrative
A getinge service representative reported that the fse that had evaluated the iabp had put the screen connector back in place, and that the iabp had been cleared to be used after his intervention mentioned in the initial emdr.
Additional Manufacturer Narrative
In the initial emdr was reported that the getinge field service engineer (fse) was unable to duplicate the reported issue; however, the fse was able to duplicate the reported issue.When the fse touched the display or moved it there was some perturbations.It was the same when the customer transferred the iabp in another room.The fse opened the display and detected the display cable was not well plugged on the video receiver board.The fse only reconnected this cable and checked the display by moving it very hardly to make sure the connector did not move.The iabp had been cleared to be used clinically after this intervention.Analysis of production: (3331) the device history record review concluded that there were no ncmrs, rework, or deviations documented for the reported 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) the review of the historical data indicates that no other similar complaint was reported for the same serial number and reported failure mode.Trend analysis: (4110) the overall 12 month product complaint trend data for the period jan-2020 through dec-2020 was reviewed.There were no triggers identified for the review period.

• Brand Name: CS300
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP. - MAHWAH; 1300 macarthur blvd; mahwah NJ 07430
• MDR Report Key: 11178624
• Report Number: 2249723-2021-00081
• Device Sequence Number: 16872462
• Product Code: DSP
• UDI-Device Identifier: 10607567107509
• UDI-Public: 10607567107509
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2021

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: 0998-00-3013-64
• Device Catalogue Number: 0998-00-3013-64
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 04/01/2021; 09/23/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 04/23/2021; 10/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1