AIRFLOW
Received Mar 13, 2020 · Event occurred Feb 14, 2020
Report 1314417-2020-00015 · MDR key 9829044
Device
Product problems
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS FOUND DAMAGED PER THE CUSTOMER'S COMPLAINT DESCRIPTION. THE DAMAGE IS NOT BELIEVED TO BE A RESULT OF SUNMED MANUFACTURING PROCESS AS VISUAL DEFECTS ARE SORTED 100% DURING ASSEMBLY PROCESSES AT MULTIPLE STAGES. FURTHER FUNCTIONAL TESTING OF THE PRODUCT DURING IN-PROCESS STAGES WOULD NOT ALLOW PRODUCT IN THIS CONDITION TO ESCAPE. THE DAMAGE IS BELIEVED TO BE FROM UNKNOWN SOURCES SUCH AS TRANSIT, MATERIAL STORAGE CONDITIONS, AMONG OTHER UNKNOWN SOURCES.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "RESUS BAG HAS A BROKEN PART." NO OTHER DETAILS WERE PROVIDED AND NO PATIENT INJURY/HARM REPORTED.