MAUDE Adverse Event Report: ESAOTE NORTH AMERICA, INC. SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Model Number MY LAB ALPHA

Device Problems Smoking (1585); Sparking (2595)

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

Event Date 12/05/2019

Event Type  Injury  

Event Description

The ultrasound machine wasn't connecting to the electricity so the tech plugged it into another outlet and the machine then sparked and began to smoke.It was immediately unplugged.No one was injured.Fda safety report id# (b)(4).

• Brand Name: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): ESAOTE NORTH AMERICA, INC.
• MDR Report Key: 9445197
• MDR Text Key: 170344114
• Report Number: MW5091550
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MY LAB ALPHA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 91