MAUDE Adverse Event Report: MABIS HEALTHCARE/ DMS HOLDINGS, INC MINIBREEZE ULTRASONIC NEBULIZER

Model Number 40-370-000

Device Problems Device Emits Odor (1425); Overheating of Device (1437)

Patient Problem Asthma (1726)

Event Date 03/27/2017

Event Type  Injury  

Event Description

Portable nebulizer mabis minibreeze ultrasonic nebulizer quit working.Battery was hot and smelled funny when plugged in.Had to have my husband deliver my other nebulizer to stop a severe asthma attack.Attempted to contact the manufacturer, but their web form is not working and they only accept calls from 8 to 5 m-f est.I work 7-5:30.

• Brand Name: MINIBREEZE ULTRASONIC NEBULIZER
• Type of Device: MINIBREEZE ULTRASONIC NEBULIZER
• Manufacturer (Section D): MABIS HEALTHCARE/ DMS HOLDINGS, INC
• MDR Report Key: 6456381
• MDR Text Key: 71752081
• Report Number: MW5068868
• Device Sequence Number: 0
• Product Code: CAF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 40-370-000
• Device Catalogue Number: R8-02LA
• Device Lot Number: 4774200115
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: ALBUTEROL NEBULIZER; COMBIVENT INHALER; IPRATROPIUM NEBULIZER; OTC MEDS: NA; RESCUE INHALER; RX MEDS: HOME NEBULIZER; SINGULAIR; SYMBICORT
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 68