MAUDE Adverse Event Report: ACCUTRON ACCUTRON; GAS-MACHINE, ANESTHESIA

Model Number 26400

Device Problem Fire (1245)

Patient Problem Injury (2348)

Event Date 03/26/2018

Event Type  Injury  

Event Description

Accutron nitrous mixer was utilized on a pt and when switching first oxygen tank off and second oxygen tank was activated, the unit caught fire and injured an employee using the device.

• Brand Name: ACCUTRON
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): ACCUTRON
• MDR Report Key: 7378195
• MDR Text Key: 103716476
• Report Number: MW5076192
• Device Sequence Number: 1
• Product Code: BSZ
• 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: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 26400
• Was Device Available for Evaluation?: Yes
• 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): Hospitalization
• Patient Age: 25 YR