MAUDE Adverse Event Report: GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO. LT DALTON OXYGEN CONCENTRACTOR; OXYGEN CONCENTRATOR,

Model Number	OZ-5-02TWO
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12/8/2023, dalton has been notified by customer (b)(6) of (b)(6).He stated that the oxygen concentrator they purchased from dalton was on fire and patient is a smoker.The serial no.Of the oxygen concentrator is (b)(6).He didn't release patient information to us.

• Brand Name: DALTON OXYGEN CONCENTRACTOR
• Common Device Name: OXYGEN CONCENTRATOR,
• Manufacturer (Section D): GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO. LT; room a101, no. 5 kesheng road; guangzhou private science; guangzhou city, gangzhou private 51054 0; CH 510540
• MDR Report Key: 18479786
• Report Number: 1649595-2024-00001
• Device Sequence Number: 17873511
• Product Code: CAW
• UDI-Device Identifier: 00815027012512
• UDI-Public: 00815027012512
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2024
• Report Date (Section F): 01/08/2024

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
• Device Model Number: OZ-5-02TWO
• Device Catalogue Number: R-DOC5200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/08/2023
• Device Age: 5 MO
• Date Report to Manufacturer: 01/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/08/2024