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

Model Number HCS70004

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

Smoke came out.

Manufacturer Narrative

According to the customer contact, on (b)(6) 2022 after the devices second use, "smoke came out of the green button." the device was in use in the home of a patient.It was reported that the device was replaced after the incident occurred.The customer contact reported that there was no injury to the patient due to the reported incident.It was reported that no medical treatment was required.The sample was evaluated but a root cause could not be determined.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: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16403639
• MDR Text Key: 310129444
• Report Number: 1417592-2023-00064
• 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: 02/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: HCS70004
• Device Catalogue Number: HCS70004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2023
• Date Manufacturer Received: 02/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other