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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION CE MOTOR DRIVE SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC Back to Search Results
Model Number 8725
Device Problems Computer Software Problem (1112); Failure to Power Up (1476)
Patient Problem No Patient Involvement (2645)
Event Date 05/08/2020
Event Type  malfunction  
Event 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.
 
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Brand NameCE MOTOR DRIVE
Type of DeviceSYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
SAN JOSE FACILITY
150 baytech drive
san jose CA 95134
Manufacturer Contact
jay johnson johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10133046
MDR Text Key194479396
Report Number2134265-2020-07513
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K151613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8725
Device Catalogue Number8725
Device Lot Number0000010243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

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