MAUDE Adverse Event Report: FEELIFE HEATH INC. SUNSET PORTABLE MESH NEBULIZER WITH RECHARGEABLE BATTERY

Model Number	NEB402
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported while charging the unit, he/she began to smell melted plastic and burning evidence showed the charging port overheated and burnt.No reports of injury was received.Medical intervention was not required.

• Brand Name: SUNSET PORTABLE MESH NEBULIZER WITH RECHARGEABLE BATTERY
• Common Device Name: PORTABLE MESH NEBULIZER
• Manufacturer (Section D): FEELIFE HEATH INC.; rm1903, 2002, bldg a, no.9; furong rd. tantou community; songgang st., bao'an district, shenzhen 51810 4; CH 518104
• Manufacturer (Section G): FEELIFE HEALTH INC.; rm1903, 2002, bldg a, no.9; furong rd. tantou community; songgang st., bao'an district, shenzhen 51810 4; CH 518104
• Manufacturer Contact: yedda zeng ; rm1903, 2002, bldg a, no.9; furong rd. tantou community; songgang st., bao'an district, shenzhen 51810-4 ; CH 518104
• MDR Report Key: 20008738
• Report Number: 3006446479-2024-00003
• Device Sequence Number: 7201581
• Product Code: CAF
• UDI-Device Identifier: 00848530098537
• UDI-Public: (01)00848530098537
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: NEB402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose