MAUDE Adverse Event Report: GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO. LTD DALTON OXYGEN CONCENTRATOR

Model Number	OZ-5-02TW0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
1) on (b)(6), 2023, dalton medical has done an onsite inspection at memorial hernamm health in (b)(6), tx.The inspection included the transformer and inner materials.We taken photos and there is nothing found with the machine (see file attachment: evidence 1 of 1).2) on (b)(6), 2023, we have been notified by the customer: max from memorial hermann health system of (b)(6), texas.Per max, they had reported to fda regarding an oxygen concentrator that we sold to them caugh on fire at patient site that damaged the carpet (see file attachment: mdr report mw5144602by the initial reporter).3) we asked them to provide us with more information about this incident.We will issue a ups call-tag to get the concentrator back for immediately investion by the device manufacturer.4) memorial hermann health system emailed us with the photos of oxygen concentrator relating the incident.5 dalton medical emailed the photos to the device manufacturer for analysis.6) the deivice manufacturer concluded that the fire combustion at the time was on the outer surface of the oxygen concentrator machine but not the internal combustion of the machine.The device manufacturer's report also assessed the fire combustion was caused by the linear objects on the carpet or person smoked around the oxygen concentrator machine (see file attachment: analysis for the fire incident report).

• Brand Name: DALTON OXYGEN CONCENTRATOR
• Common Device Name: OXYGEN CONCENTRATOR
• Manufacturer (Section D): GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO. LTD; room a101. no. 5 kesheng road,; guangzhou private science and; guangdon, cn 51054 0; CH 510540
• MDR Report Key: 17654798
• Report Number: 1649595-2023-00001
• Device Sequence Number: 15035719
• Product Code: CAW
• UDI-Device Identifier: 00815027012512
• UDI-Public: 00815027012512
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 08/14/2023
• Report Date (Section F): 08/30/2023

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: OZ-5-02TW0
• Device Catalogue Number: R-DOC5200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/15/2023
• Device Age: 1 MO
• Event Location: Home
• Date Report to Manufacturer: 08/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/30/2023
• 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: Female
• Date Report Sent to FDA: 08/30/2023