RESMED AIR TOUCH F20
Received May 9, 2019 · Event occurred Apr 25, 2019
Report MW5086504 · MDR key 8597018
Device
Product problems
- Labelling, Instructions for Use or Training Problem
Patient
80 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
I RECENTLY RECEIVED A CPAP MASK THAT DID NOT HAVE THE PROPER WARNING NOTICE ON THE PACKAGING. THE MASK USES MAGNETS TO SECURE IT TO THE FACE. THE MASK WAS NOT TO BE USED BY PTS WITH PACEMAKERS. I BELIEVE THE WARNING NOTICE, "DO NOT USE IF YOU HAVE A PACEMAKER", SHOULD BE PRINTED ON THE OUTSIDE OF THE CONTAINER. ONCE I OPENED THE PACKAGE IT WAS NOT RETURNABLE. HAD I READ THE WARNING NOTICE BEFORE I OPENED THE PACKAGE AND READ THE NOTICE ON THE ENCLOSED BOOKLET. I BELIEVE THIS WARNING NOTICE, "DO NOT USE IF YOU HAVE A PACEMAKER" SHOULD BE BOLDLY PRINTED ON THE OUTSIDE OF THE CONTAINER.