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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VIVID S60; ULTRASOUND IMAGING SYSTEM
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VIVID S60; ULTRASOUND IMAGING SYSTEM Back to Search Results
Model Number UVS60A
Device Problem Arcing (2583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2021
Event Type  malfunction  
Manufacturer Narrative
Legal manufacturer: (b)(4).
 
Event Description
The customer states that when they came into the office, first thing in the morning, they observed a burning smell and found that at the back of the vivid s60 electric outlet is black as if it got on fire.
 
Manufacturer Narrative
Gehcs investigation has completed.The device components involved in the thermal event were returned to gehc for analysis.Both gehc and the manufacturers of the components analyzed the components.The conclusion is that most probably a high resistance short between the power cable plug and ac receptacle caused by insufficient seating of the power cable plug caused the thermal event.The vivid s60 system is designed to prevent fire according to iec-60601-1, and gehc concluded these mitigations were effective, as no fire was spread from the incident.No design, manufacturing or service root cause was identified.The vivid s60s damaged components were replaced to correct the issue.No further actions are planned at this time.
 
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Brand Name
VIVID S60
Type of Device
ULTRASOUND IMAGING SYSTEM
MDR Report Key11789900
MDR Text Key280511968
Report Number9615849-2021-00003
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
PMA/PMN Number
K142323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUVS60A
Device Lot Number000782S60
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/07/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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