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

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.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.

• Brand Name: MYLABGAMMA
• 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: 10290229
• MDR Text Key: 246115152
• Report Number: 9611125-2020-00002
• 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: distributor
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2020
• 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 7410
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1