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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.
 
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.
 
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.
 
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Brand Name
CE MOTOR DRIVE
Type of Device
SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10133046
MDR Text Key194479396
Report Number2134265-2020-07513
Device Sequence Number1
Product Code DQK
UDI-Device Identifier08714729401094
UDI-Public08714729401094
Combination Product (y/n)N
PMA/PMN Number
K151613
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was 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 Health Professional
Device Model Number8725
Device Catalogue Number8725
Device Lot Number0000010243
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2020
Date Manufacturer Received12/02/2020
Patient Sequence Number1
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