INOVO INC.
Received Feb 21, 2024 · Event occurred Jul 26, 2023
Report 1062191-2024-00002 · MDR key 18749618
Device
Product problems
- Thermal Decomposition of Device
- Thermal Decomposition of Device
Patient
NA · Unknown
- Superficial (First Degree) Burn
- Superficial (First Degree) Burn
Narrative
Description of Event or Problem
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.