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

Model Number OM-900A

Device Problem Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2022

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 310450726
• Report Number: 1062191-2022-00001
• Device Sequence Number: 1
• Product Code: NFB
• UDI-Device Identifier: 00822383018515
• UDI-Public: 822383018515
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K103392
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1