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

Model Number 101741000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2019

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

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
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): ESAOTE SPA; via melen 77; genoa, 16152 ; IT 16152
• Manufacturer Contact: massimo polignano ; via di caciolle, 15; firenze, fi 50127 ; IT 50127
• MDR Report Key: 10274265
• MDR Text Key: 201612026
• Report Number: 9611125-2020-00001
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 08056304450012
• UDI-Public: 08056304450012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101741000
• Device Catalogue Number: MODEL 7400
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1