MAUDE Adverse Event Report: GLOBALCARE MEDICAL TECHNOLOGY CO., LTD DRIVE; COMPRESSOR NEBULIZER

Model Number	MQ5900
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer received a complaint reporting "was using the device, the device quit working and smoke came out of the sides where there are holes".

• Brand Name: DRIVE
• Common Device Name: COMPRESSOR NEBULIZER
• Manufacturer (Section D): GLOBALCARE MEDICAL TECHNOLOGY CO., LTD; 7th building, 39 middle; industrial main road, xiao lan; zhongshan, guangdong 52841 5; CH 528415
• Manufacturer Contact: cherry feng ; 7th building, 39 middle industrial main road,; european industrial zone, xiaolan town,; zhongshan, guangdong 52841-5 ; CH 528415
• MDR Report Key: 25024118
• Report Number: 3010880718-2026-00001
• Device Sequence Number: 10261001
• Product Code: CAF
• UDI-Device Identifier: 00822383579160
• UDI-Public: 00822383579160
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K980074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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
• Device Model Number: MQ5900
• Device Catalogue Number: MQ5900
• Device Lot Number: 13M370132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Race: White