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

Model Number	101741000
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/09/2019
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
While ultrasound system was plugged into the wall socket and during use, smoke appeared to come from the ac power brick for the system (it plugs into the machine and the wall power socket).

• Brand Name: MYLABALPHA
• Common Device Name: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): ESAOTE SPA; via melen 77; genoa, 16152 ; IT 16152
• MDR Report Key: 10274265
• Report Number: 9611125-2020-00001
• Device Sequence Number: 11652045
• 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: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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 7400
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 07/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1