FDA Adverse Event
Injury
Summary report: N
RESMED CPAP MASK AIRFIT F20 & AIR SENSE 10 AUTO SET
MDR report key: 19070584
·
Received April 8, 2024
Report
- Report Number
- MW5153650
- Event Type
- Injury
- Date Received
- April 8, 2024
- Date of Event
- September 27, 2020
- Report Date
- April 4, 2024
- Manufacturer
- RESMED CORP
- Product Code
- BZD
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
- Health Professional
- *
Narratives
Description of Event or Problem · 0
UNCOMFORTABLE MASKS AND NOW RESMED MOST MASKS WERE AND ARE ON RECALLED. AIR BLOW OUT FROM RESMED CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) AIR SENSE 10 AUTO SET WITH HEATED HUMIFIED MACHINES. CHOKING TO DEATH AND SUFFERING AND STILL SUFFERING SOFT TISSUE SWELLING ALL OVER THE BODY WITH INFLAMMATION ALL OVER THE JOINTS. RESMED INC. PUSH AWAY ALL THESE SERIOUS HARMS TO DEATH FOR YEARS. VERY IRRESPONSIBLE RESMED INC ORGANIZATIONS AND VERY ABUSIVE ORGANIZATION. DON'T CARE ONLY CARE ABOUT THEIR OWN PROFITS. BURNING PAINS AND DAMAGES ORGANS INCLUDING MUSCLES, NERVES, TENDONS AND ALIGNMENTS, SWELLING FACE, CHINS, NECK, FINGERS, FEET AND LEGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 418285 | RESMED CPAP MASK AIRFIT F20 & AIR SENSE 10 AUTO SET | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | BZD | RESMED CORP | 37035 | 1411908 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Female | Life Threatening| H| S| O| R | ANTI-DEPRESSION.| MULTIVITAMINS. |