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

Model Number HCS70004

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/01/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer, when using the nebulizer he smelled 'burning wires' and saw 'a little bit of smoke' coming from the device.The customer reported there was no medical intervention or serious injury.The sample is reported to be available but has not been returned for evaluation.No additional information is available at this time.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, when using the nebulizer he smelled 'burning wires' and saw 'a little bit of smoke' coming from the device.

• Brand Name: Medline
• 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: 15598840
• MDR Text Key: 301722768
• Report Number: 1417592-2022-00193
• 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: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: HCS70004
• Device Catalogue Number: HCS70004
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/21/2022
• 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