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

Model Number 18080

Device Problems Melted (1385); Overheating of Device (1437)

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

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 310328678
• Report Number: 2438477-2023-00015
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 00822383269917
• UDI-Public: 822383269917
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 18080
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2023
• Distributor Facility Aware Date: 02/02/2023
• Device Age: 1 YR
• Date Report to Manufacturer: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1