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

Model Number	0998-00-3023-57
Medical Device Problem Codes	Battery Problem (2885); Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested, and we will report accordingly if it becomes available.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a battery issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the iabp and was unable to reproduce the reported issue.After the iabp was tested under load of tests, and the iabp was then released to the customer and cleared for clinical service.
Event or Problem Description
It was reported that the cs300 intra-aortic balloon pump (iabp) had a battery issue.It is unknown the circumstances under which the event occurred.It is also unknown if there was patient involvement.However, there was no adverse event reported.
Additional Manufacturer Narrative
Analysis of production: (3331) the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported serial number.Based on the dhr 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 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.

• 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: 11619378
• Report Number: 2249723-2021-00714
• Device Sequence Number: 11578904
• 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): 07/27/2021

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: 0998-00-3023-57
• Device Catalogue Number: 0998-00-3023-57
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/07/2021; 07/27/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 04/30/2021; 07/28/2021
• Patient Sequence Number: 1