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

Model Number	101741000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.

• Brand Name: MYLABGAMMA
• Common Device Name: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): ESAOTE SPA; via melen 77; genoa, 16152 ; IT 16152
• MDR Report Key: 10274266
• Report Number: 9611125-2020-00004
• Device Sequence Number: 17033563
• Product Code: IYO
• UDI-Device Identifier: 08056304450012
• UDI-Public: 08056304450012
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 101741000
• Device Catalogue Number: MODEL 7410
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1