AIRFLOW
Received Jan 28, 2020 · Event occurred Dec 23, 2019
Report 1314417-2020-00004 · MDR key 9636223
Device
Product problems
- Defective Device
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
THE RETURNED DEVICE WAS CONFIRMED TO BE BROKEN HOWEVER THE CAUSE FOR THE DEVICE BREAKING IS NOT KNOWN BUT BELIEVED TO BE FROM FACTORS OUTSIDE OF SUNMED MANUFACTURING PRACTICES SUCH AS BLUNT FORCE FROM DROPPING, ACCIDENTAL CONTACT WITH A HARD SURFACE, OR TRANSIT HANDLING. THERE IS NO REASON TO BELIEVE THAT THERE IS A MANUFACTURING OR PRODUCT DESIGN ISSUE AS THE OCCURRENCE IS ONE PART. SUNMED HAS TESTED PRODUCT AGAINST ISO10651-4 SECTION 5.4.1 DROP TEST AND FOUND THAT THE PRODUCT MEETS THE ISO REQUIREMENTS.
Description of Event or Problem
THE CUSTOMER ALLEGES THAT "AN AIRFLOW ADULT RESUSCITATOR W/MANOMETER, FILTER, MASK AND BAG THAT WAS DEFECTIVE. THE END OF THE GREEN UNIT THAT IS HARD PLASTIC, LOOKS LIKE IT WAS BROKEN OFF."