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

Model Number	N/A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A getinge field service engineer (fse) was dispatched to investigate.The fse evaluated the unit, but was unable to reproduce the reported issue.The fse performed all functional and safety checks to meet factory specifications.The iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that during patient transport, the cs300 intra-aortic balloon pump (iabp) was not working properly.Additionally and unrelated, it was reported that the iabp unit involved was making an odd sound.No patient harm, serious injury or adverse event was reported.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Analysis of production: (3331/213) the device history record 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 that the cs300 intra-aortic balloon pump (iabp) was not working properly.Additionally and unrelated, it was reported that the iabp unit involved was making an odd sound.It is unknown under which circumstances this event occurred; however there was no patient involvement, and no adverse event was reported.
Additional Manufacturer Narrative
After completion of the repair, the getinge field service engineer had spoken to the customer who later verified that there had not been a patient involved in this event.Additionally, the customer confirmed that the event had occurred on the night of (b)(6) 2021.

• 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: 11591115
• Report Number: 2249723-2021-00670
• Device Sequence Number: 4882077
• Product Code: DSP
• UDI-Device Identifier: 10607567108711
• UDI-Public: 10607567108711
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K063525
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2021

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-UC-3023-83
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/01/2021; 06/29/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 04/23/2021; 06/30/2021
• Patient Sequence Number: 1