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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FUJI FILM SONOSITE, INC. FUJI FILM; FUJI FILM SONOSITE PORTABLE ULTRASOUND
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FUJI FILM SONOSITE, INC. FUJI FILM; FUJI FILM SONOSITE PORTABLE ULTRASOUND Back to Search Results
Model Number M-TURBO
Device Problems Burst Container or Vessel (1074); Fire (1245)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2018
Event Type  malfunction  
Event Description
Fuji film sonosite portable ultrasound lithium battery exploded causing the unit to catch fire.The unit was not plugged into a power outlet at the time of the incident.On (b)(6) 2018 at approximately 1:00 pm, the fuji film sonosite portable ultrasound lithium battery exploded causing the unit to catch fire.According to the staff on duty, the unit was not plugged into a power outlet at the time of the incident.Although, no one was hurt during this event, the device catching fire could have resulted in an adverse outcome.
 
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Brand Name
FUJI FILM
Type of Device
FUJI FILM SONOSITE PORTABLE ULTRASOUND
Manufacturer (Section D)
FUJI FILM SONOSITE, INC.
21919 30th drive se
bothell WA 98021 3904
MDR Report Key7241895
MDR Text Key99117888
Report Number7241895
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM-TURBO
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2018
Distributor Facility Aware Date01/23/2018
Device Age3 YR
Event Location Hospital
Date Report to Manufacturer01/23/2018
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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