HUDSON MASK,MULTI-VENT,ADULT
Received Apr 1, 2019 · Event occurred Mar 1, 2019
Report 3004365956-2019-00091 · MDR key 8468865
Device
Generic name
Mask, Oxygen, Low Concentratio
Manufacturer
Teleflex MedicalCatalog number
1088
Lot number
74C1600188
Product problems
- Gas/Air Leak
- Gas/Air Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION AT THE TIME OF THIS REPORT. THE DEVICE HISTORY RECORD (DHR) OF BATCH NUMBER 74C1600188 THAT BELONGS TO CATALOG NUMBER 1088 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY BE RELATED TO THIS COMPLAINT. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. TO PERFORM A PROPER AND THOROUGH INVESTIGATION, IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. CUSTOMER COMPLAINT CANNOT BE CONFIRMED BASED ONLY ON THE INFORMATION PROVIDED. ROOT CAUSE CANNOT BE DETERMINED. CORRECTIVE ACTIONS CANNOT BE ESTABLISHED. IF THE SAMPLE BECOMES AVAILABLE THIS REPORT WILL BE UPDATED WITH THE EVALUATION RESULTS.
Description of Event or Problem
CUSTOMER COMPLAINT ALLEGES "SHE IS NOT GETTING ENOUGH OXYGEN. THE MASK BLOWS MORE AIR INTO EYES THAN NOSE AND THE METAL PIECE OVER BRIDGE OF NOSE IS OFF TO THE SIDE". NO PATIENT HARM WAS REPORTED. PATIENT CONDITION REPORTED AS FINE.