MalfunctionBTM
AIRFLOW
Received Nov 15, 2017
Report 2246980-2017-00031 · MDR key 7033439
Device
Product problems
- Insufficient Device Problem Information
- Missing Value Reason
- Insufficient Device Problem Information
- Missing Value Reason
Patient
Not reported
- No Known Impact Or Consequence To Patient
- Missing Value Reason
- No Known Impact Or Consequence To Patient
- Missing Value Reason
Narrative
Additional Manufacturer Narrative
DURING THE COURSE OF THE PRODUCT INVESTIGATION, VISUAL AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED PRODUCT. THE INVESTIGATION CONFIRMED THE CUSTOMER CLAIM AND A NONCONFORMANCE HAS BEEN OPENED TO GARNER FURTHER INVESTIGATION.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "MASK AND SOME CONNECTORS ARE MISSHAPEN. THEY DO NOT FIT ONTO THE BAG OR SEAL CORRECTLY." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.