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

Model Number	OM-900A
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Inovo inc.Was notified of an incident involving an oxygen conserver by a provider who stated that "a patient had fitted the conserver onto a ch medical oxygen cylinder but did not turn it on.Approximately 24 hours later, the patient needed to visit the gp and when outside the gp's clinic they turned it on.At that point the patient heard a hissing noise and then a bang." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Inovo evaluated the product, which revealed that the ignition mechanism was flow friction, which can occur if the seal washer wears over time, or if the device is not connected to the compressed oxygen cylinder tightly enough, both of which are addressed by the device's instructions for use.

• Brand Name: INOVO
• 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: jillian forster ; 401 leonard blvd n; lehigh acres, FL 33971 ; 5169984600
• MDR Report Key: 16460357
• Report Number: 1062191-2022-00001
• Device Sequence Number: 2315988
• Product Code: NFB
• UDI-Device Identifier: 00822383018515
• UDI-Public: 822383018515
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 03/01/2023

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-900A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2022
• Initial Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown