AIRFLOW
Received Oct 14, 2019
Report 1314417-2019-00057 · MDR key 9186863
Device
Product problems
- Device Misassembled During Manufacturing /Shipping
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER OF THE NEW GCES MEDIVITAL VALVE AND THE EMAIL CORRESPONDENCE INDICATES THERE WERE NO DEFECTS WITH THE RESUSCITATION BAGS, THE DEVICE FUNCTIONED AS INTENDED. ON THE GCE MEDIVITAL VALVE, THERE IS A GREY RIDGE OR LIP ON THE VALVE THAT PREVENTS THE UNIVERSAL CONNECTOR FROM MAKING A CONNECTION. THE UNIVERSAL CONNECTOR IS NOT COMPATIBLE WITH THE NEW GCE MEDIVITAL VALVE. THE END CONNECTOR COMPLIES WITH BS EN 13544-2 RESPIRATOR THERAPY EQUIPMENT - PART 2: TUBING AND CONNECTORS.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "AIRFLOW BAG TUBING CONNECTOR COMING UNATTACHED FROM THE OXYGEN TANK." NO OTHER DETAILS WERE PROVIDED.