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 03/20/2023

Event Type  Injury  

Event Description

According to the facility "the customer was using the device when the nebulizer began to spark and smoke".

Manufacturer Narrative

According to the facility "the customer was using the device when the nebulizer began to spark and smoke".Per the facility the spark and smoke were visually confirmed by the customer, and when the facility went to replace the item "the device had physical deformities resembling melting, including brown coloring".Per the facility the device was not damaged or exposed to water prior to the event occurring and was in working condition prior to the reported incident.The device was reported to be "roughly a year old" and was provided by the medical device distributor.No additional information is available at this time.The sample was discarded and is not available to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• 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: 16663616
• MDR Text Key: 312516049
• Report Number: 1417592-2023-00148
• 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: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HCS70004
• Device Catalogue Number: HCS70004H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other