MAUDE Adverse Event Report: INOVO INC. INOVO INC.; CONSERVER, OXYGEN

Model Number	OM-900
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Inovo previously reported 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 was returned for investigation.The device experienced an external ignition event originating at the connection of the seal washer with the cga valve.The event was likely caused by an unauthorized servicing/tampering with the device and installation of non -manufacturer approved seal washer.The manufacturer incorrectly reported this report on fei (b)(4).
Additional Manufacturer Narrative
Inovo inc.Previously reported the incorrect date for section g3, date received by manufacturer as 7/26/2023.The correct date for section g3, date received by manufacturer is 1/3/2024.
Additional Manufacturer Narrative
Inovo inc.Previously reported the incorrect date for section g3, date received by manufacturer as 7/26/2023.The correct date for section g3, date received by manufacturer is 2/15/2024.

• Brand Name: INOVO INC.
• Common Device Name: CONSERVER, OXYGEN
• Manufacturer (Section D): INOVO INC.; 401 leonard blvd. n; lehigh acres FL 33971
• Manufacturer (Section G): INOVO INC.; 401 leonard blvd. n; lehigh acres FL 33971
• Manufacturer Contact: jess bohrer ; 99 seaview blvd.; port washington, NY 11050
• MDR Report Key: 18749618
• Report Number: 1062191-2024-00002
• Device Sequence Number: 6271164
• Product Code: NFB
• UDI-Device Identifier: 00814470020044
• UDI-Public: 00814470020044
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K103392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2024

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: OM-900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 02/15/2024; 02/15/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/17/2024; 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown