MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-09 for RESMED AIR TOUCH F20 manufactured by Resmed Corp..
[144674793]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086504 |
| MDR Report Key | 8597018 |
| Date Received | 2019-05-09 |
| Date of Event | 2019-04-25 |
| Date Added to Maude | 2019-05-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RESMED AIR TOUCH F20 |
| Generic Name | STRAP, HEAD, GAS MASK |
| Product Code | BTK |
| Date Received | 2019-05-09 |
| Model Number | AIR TOUCH F20 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-09 |