MAUDE Adverse Event Report: SHENZHEN HOMED MEDICAL DEVICE CO LTD DRIVE; NEBULIZER

Model Number	18080
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a nebulizer by an end user, who stated that "they were using the unit and the compressor became hot and melted the tubing just past where the tubing connects to the unit." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: NEBULIZER
• Manufacturer (Section D): SHENZHEN HOMED MEDICAL DEVICE CO LTD; huarong road, dalang street; 3rd floor, block1; shenzhen city, guangdong 51810 9; CH 518109
• MDR Report Key: 16451659
• Report Number: 2438477-2023-00015
• Device Sequence Number: 5860326
• Product Code: CAF
• UDI-Device Identifier: 00822383269917
• UDI-Public: 822383269917
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/27/2023
• Report Date (Section F): 02/27/2023

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: 18080
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/02/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 03/07/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/27/2023