MAUDE Adverse Event Report: MABIS HEALTHCARE MABIS; PERSONAL STEAM INHALER

Model Number 40-741-000

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Explosion (4006)

Patient Problem Burn, Thermal (2530)

Event Date 08/11/2019

Event Type  No Answer Provided  

Event Description

It was the 2nd time i was using the steam inhaler, which is needed for my chronic bronchitis.A minute or two after the warm-up period, the unit blew-up and spewed steam and boiling water.My left arm was scalded slightly with slight burns.I have been using this particular model for a few years and a typical unit lasts only a few months.This subject unit was brand new out of box.Steamer was purchased through (b)(6).I was very careful to follow the manufacturer¿s instructions.Unit model # 40-741-000, serial # (b)(4).Distributer: (b)(4).Referring to manufacturer¿s product identification diagram ¿ the incident was caused because the lid popped off the internal water heater tank and due to the steam pressure inside the tank, all the water and steam was expelled suddenly.Secondly, a scan of the unit as depicted in the owners handbook.Referring to the handbook depiction, the lid broke lose from the lower internal water heater tank.When this occurred, the mask, extension tube and the cover all separated from the lower unit.Considering the fact that a person¿s face is set in the mask, there is potential for serious injury.Not only did i receive a spray and a splash from the unit when it exploded, but my wife, who was sitting across the table from me was affected also (fortunately no injury.) retailer state: (b)(6).Purchase date: 06/05/2019 this date is an estimate.I still have the product in my possession: yes.Explanation: i have retained the steamer.

• Brand Name: MABIS
• Type of Device: PERSONAL STEAM INHALER
• Manufacturer (Section D): MABIS HEALTHCARE
• MDR Report Key: 8951045
• MDR Text Key: 156155847
• Report Number: MW5089484
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 40-741-000
• Type of Device Usage: N
• Patient Sequence Number: 1