MAUDE Adverse Event Report: INOVO INC INOVO; CONSERVER

Model Number	OM-900
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Malfunction
Event or Problem Description
Inovo was notified by a home oxygen provider of an incident involving an oxygen conserving device.The provider reported that the end-user stated he installed [attached] the conserver onto a cga-870 oxygen cylinder.After attaching the conserving device, he "opened the cylinder with a plastic wrench" and then "heard a leak and saw a spark and a flame," which he claimed caused a small burn on his finger.He immediately turned the cylinder off to stop the flow of oxygen.The end-user did not seek medical attention for the alleged injury.The information presented is consistent with an event that may occur when a conserving regulator is not properly attached to the cylinder, allowing for a high-pressure leak.The device is being returned to inovo for investigation and root cause analysis.An update will be filed if additional information becomes available.

• Brand Name: INOVO
• Common Device Name: CONSERVER
• Manufacturer (Section D): INOVO INC; 104 leonard blvd. n; lehigh acres FL 33971
• MDR Report Key: 17614477
• Report Number: 3005328749-2023-00002
• Device Sequence Number: 12449180
• Product Code: NFB
• UDI-Device Identifier: 00814470020044
• UDI-Public: 00814470020044
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2023
• Report Date (Section F): 08/24/2023

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: OM-900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2023
• Device Age: 4 YR
• Date Report to Manufacturer: 08/24/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/24/2023