MalfunctionBYF
ADULT OXYGEN MASK WITH TUBING,02 DILUTER JETS (6),OXYGEN TUBE, NEBULIZER HOOD
Received Nov 5, 2015 · Event occurred Oct 22, 2014
Report 9680866-2015-31375 · MDR key 5204466
Device
Generic name
Mask, Oxygen, Low Concentration, Venturi
Manufacturer
Unomedical Sa De CvModel number
I002610Product problems
- Air Leak
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
CONVATEC IS SUBMITTING THIS REPORT AS A RESULT OF ACTIVITIES RELATED TO CONVATEC REMEDIATION PROTOCOL (B)(4). CONVATEC IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT WILL BE FILED ON A SUPPLEMENTAL REPORT (MEDWATCH 3500A).
Description of Event or Problem
CUSTOMER REPORTED THAT THE WHISTLE SOUND WAS HEARD FROM THE CONNECTION BETWEEN THE OXYGEN AND THE FLOWMETER, SO THE DEVICE WAS CHANGED TO THE NEW ONE.