MAUDE Adverse Event Report: ACCUTRON DIGITAL ULTRA FLOWMETER; NITROUS MIXER

Model Number 56100

Device Problem Gas/Air Leak (2946)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/28/2018

Event Type  Injury  

Manufacturer Narrative

A facility reported that the accutron nitrous mixer unit caught fire and injured a dental assistant employee while switching from the first oxygen tank to the second oxygen tank.This employee suffered 2nd degree burns to both the left hand and right thigh.That same day, they were sent to burn unit at uab where they received wound care treatment.The employee was discharged the same day and given instructions on wound care treatment to perform.Accutron qa followed up directly with the facility.It was confirmed that there was no patient in the room and no other personnel was injured as a result of this incident.Dr.(b)(6), the facility dentist who was in the next room indicated that the fire came out of the front near the "empty" cylinder upon changing over to the reserve back cylinder.The fire depleted quickly and no external extinguishing methods were necessary.Dr.(b)(6) also reported that he identified a gas leak with the equipment a week earlier before the incident.There was no reported safety actions taken to resolve or investigate the source of the gas leak before the incident occurred which is not compliant with the nitrous mixer's ifu required training on nitrous oxide use.After detailed review of the provided information and condition of the equipment returned, there is potential that the check valve became contaminated (particulate debris) during their equipment transport between various offices and did not fully close.The reserve cylinder having a (contaminated) check valve could cause a gas leak.Dr.(b)(6) indicated that the cylinders are taken off the manifold during routine transport between facilities which could potentially expose the manifold ports to contaminants.Dr.(b)(6) stated that he does not think the problem was with the nitrous mixer unit.The oxygen cylinder is currently under investigation by (b)(4), distributor/filler of the gas cylinders.This is an isolated incident that will continue to be monitored in accutron's complaint handling system.(b)(6).

Event Description

A facility reported that the accutron nitrous mixer unit caught fire and injured a dental assistant employee while switching from first oxygen tank to the second oxygen tank.

• Brand Name: DIGITAL ULTRA FLOWMETER
• Type of Device: NITROUS MIXER
• Manufacturer (Section D): ACCUTRON; 1733 west parkside ln; pheonix AZ 85027
• Manufacturer (Section G): ACCUTRON; 1733 w. parkside ln; pheonix AZ 85027
• Manufacturer Contact: megan dickey ; 1733 w parkside ln; pheonix, AZ 85027
• MDR Report Key: 7465840
• MDR Text Key: 106663350
• Report Number: 2020813-2018-00001
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 00813830023374
• UDI-Public: 00813830023374
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052335
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dental Assistant
• Device Model Number: 56100
• Device Lot Number: 9286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: AIRGAS OXYGEN FILLED CYLINDER
• Patient Outcome(s): Other
• Patient Age: 26 YR