MAUDE Adverse Event Report: SHENZHEN HOMED MEDICAL DEVICECO LTD POWER NEB ULTRA NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	18080
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	11/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a nebulizer by the end user who stated that the nebulizer came without instructions for assembly or use.Upon needing to use the nebulizer, the end user reported wasting minutes attempting to locate assembly instructions and putting the nebulizer together without success.This resulted in calling an ambulance for transportation to the hospital.The end user reported spending the day in the er for monitoring and receiving breathing treatments and was then discharged.This is the only complaint for this product with this issue in the past three years.Attempts to gather additional information about the patient's source for the product or a serial number have been unsuccessful.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: POWER NEB ULTRA NEBULIZER
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): SHENZHEN HOMED MEDICAL DEVICECO LTD; block 2, huawang road; tongsheng community, dalang st; shenzhen, longhua new district 51810 9; CH 518109
• MDR Report Key: 21583690
• Report Number: 2438477-2025-00015
• Device Sequence Number: 12985747
• Product Code: CAF
• UDI-Device Identifier: 00822383269917
• UDI-Public: (01)00822383269917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2025
• Report Date (Section F): 03/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 18080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/26/2024
• Event Location: Home
• Date Report to Manufacturer: 03/11/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/12/2025