MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; COMPRESSOR,NEBULIZER,AEROMIST COMPACT

Catalog Number HCS70004

Device Problems Fire (1245); Smoking (1585)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/17/2022

Event Type  malfunction  

Manufacturer Narrative

According to the customer they were using a nebulizer when the device began to smoke and catch fire.According to the customer he received the nebulizer in mid-january.He uses the nebulizer twice daily and he reported that there was no physical damage or water damage to the device.On (b)(6) 2022 the customer reported that he was using the device as usual and after approximately 10min the nebulizer began to smoke and catch on fire.At this time the customer unplugged the device and was able to extinguish the fire without injury.The customer reported that he did not require any medical attention or intervention.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer they were using a nebulizer when the device began to smoke and catch fire.

• Type of Device: COMPRESSOR,NEBULIZER,AEROMIST COMPACT
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13897185
• MDR Text Key: 298039746
• Report Number: 1417592-2022-00046
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00884389106870
• UDI-Public: 00884389106870
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: HCS70004
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male