MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CE MOTOR DRIVE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number	8725
Medical Device Problem Codes	Computer Software Problem (1112); Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the system is not booting.A ce motor drive was selected to be used for a procedure.Prior to the procedure, the system was not booting.The procedure was unable to be completed due to this event and it was unknown if the patient was sedated.The patient was stable and no patient complications occurred.
Event or Problem Description
It was reported that the system is not booting.A ce motor drive was selected to be used for a procedure.Prior to the procedure, the system was not booting.The procedure was unable to be completed due to this event and it was unknown if the patient was sedated.The patient was stable and no patient complications occurred.
Additional Manufacturer Narrative
H6 device codes corrected.The acquisition (acq) and imaging (img) computers (pc) were returned for analysis.A functional test and virus scan of the img pc revealed no issues.A functional test of the acq pc revealed the acq pc failed start up; the power supply was found to be at fault.

• Brand Name: CE MOTOR DRIVE
• Common Device Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10133046
• Report Number: 2134265-2020-07513
• Device Sequence Number: 3791756
• Product Code: DQK
• UDI-Device Identifier: 08714729401094
• UDI-Public: 08714729401094
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K151613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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: Health Professional
• Device Model Number: 8725
• Device Catalogue Number: 8725
• Device Lot Number: 0000010243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Received by Manufacturer: 05/12/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 06/09/2020
• Supplement Report FDA Received Date: 12/11/2020
• Patient Sequence Number: 1