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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ESAOTE SPA MYLABGAMMA; DIAGNOSTIC ULTRASOUND SYSTEM

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ESAOTE SPA MYLABGAMMA; DIAGNOSTIC ULTRASOUND SYSTEM Back to Search Results
Model Number 101741000
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/17/2020
Event Type  malfunction  
Manufacturer Narrative
The ac inlet solder joint has been damaged by excessive mechanical stress exerted on the joint via the ac cord either by multiple plugging/unplugging or by direct mechanical stress to the ac cord.
 
Event Description
Customer reported that they saw smoke coming out of the dc adapter.They immediately unplugged the cord and did not use it again.There were no injuries or other damage reported.
 
Manufacturer Narrative
The ac inlet solder joint has been damaged by excessive mechanical stress exerted on the joint via the ac cord either by multiple plugging/unplugging or by direct mechanical stress to the ac cord.Sending follow up to fda maude.
 
Event Description
Customer reported that they saw smoke coming out of the dc adapter.They immediately unplugged the cord and did not use it again.There were no injuries or other damage reported.
 
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Brand Name
MYLABGAMMA
Type of Device
DIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer (Section D)
ESAOTE SPA
via melen 77
genoa, 16152
IT  16152
MDR Report Key10274266
MDR Text Key201614211
Report Number9611125-2020-00004
Device Sequence Number1
Product Code IYO
UDI-Device Identifier08056304450012
UDI-Public08056304450012
Combination Product (y/n)N
PMA/PMN Number
K161359
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Remedial Action Replace
Type of Report Initial,Followup
Report Date 07/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number101741000
Device Catalogue NumberMODEL 7410
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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