MAUDE Adverse Event Report: VEGA TECHNOLOGIES INC. DRIVE; NEBULIZER

Model Number	18081
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sore Throat (2396)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Devilbiss healthcare received a medwatch report regarding an incident involving an oxygen concentrator, which states "patient smoking with oxygen on and sustained second degree burns to face." there is no statement or evidence in the report suggesting the oxygen concentrator malfunctioned or in any way caused or contributed to the patient injury.The unit was returned to devilbiss for evaluation, and the evidence indicates the root cause of the thermal damage to the unit was the result of an external heat/fire source, which is consistent with the report of the patient smoking while using the oxygen concentrator.The unit was repaired and is operating to specification.".
Event or Problem Description
(b)(6) healthcare was notified of an incident involving the tubing of an end users nebulizer becoming very warm to the touch.The reporter of the incident indicated that the end user sustained a yeast infection in her throat which became blistered.The reporter of the incident indicated that it was unclear if the injury was from the medicine or a combination of the heat, which they felt was excessive.There was no information regarding an medical attention received.Multiple attempts were made to obtain additional information.Repeated attempts to obtain additional information and arrange for the device to be returned for evaluation and investigation were unsuccessful.(b)(6) healthcare believes they will be unable to gather additional information.If pertinent information becomes available at a later date, an addendum to this report will be filed.
Additional Manufacturer Narrative
(b)(6) healthcare previously reported in section b5 of receiving a medwatch report regarding an incident involving an oxygen concentrator, which states "patient smoking with oxygen on and sustained second degree burns to face." there is no statement or evidence in the report suggesting the oxygen concentrator malfunctioned or in any way caused or contributed to the patient injury.The unit was returned to (b)(6) for evaluation, and the evidence indicates the root cause of the thermal damage to the unit was the result of an external heat/fire source, which is consistent with the report of the patient smoking while using the oxygen concentrator.The unit was repaired and is operating to specification." this was not the correct narrative for this submission.This issue was reported on mdr 2515872-2022-00112.The correct narrative for this issue is in section b5 of this report.

• Brand Name: DRIVE
• Common Device Name: NEBULIZER
• Manufacturer (Section D): VEGA TECHNOLOGIES INC.; yangwu district; dalang town; dongguan, guangdong 52378 9; CH 523789
• MDR Report Key: 15550733
• Report Number: 2438477-2022-00082
• Device Sequence Number: 2796755
• Product Code: CAF
• UDI-Device Identifier: 00822383504131
• UDI-Public: 00822383504131
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023
• Report Date (Section F): 11/16/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 18081
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/28/2022
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 11/16/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/16/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 11/16/2023