FDA Adverse Event
Injury
Summary report: N
RESMED AIR 10
MDR report key: 13076994
·
Received December 22, 2021
Report
- Report Number
- MW5106244
- Event Type
- Injury
- Date Received
- December 22, 2021
- Date of Event
- October 1, 2021
- Report Date
- December 20, 2021
- Manufacturer
- RESMED ASIA PTE. LTD.
- Product Code
- LRJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
COUGHING, NASAL, NAUSEA; I HAVE BEEN EXPERIENCING A CHRONIC COUGH AND COUGHING FITS WHEN USING MY CPAP (RESMED AIR 10) FOR AT LEAST A COUPLE OF MONTHS. AT FIRST, I DID NOT EQUATE IT TO USING THE CPAP. RECENTLY I HAVE BEEN EXPERIENCING NAUSEA WITHIN AN HOUR OR TWO OF USING THE CPAP. I HAVE BEEN USING THE SOCLEAN 2 CLEANER SINCE I PURCHASED IT ON (B)(6) 2018 FROM (B)(6). FDA SAFETY REPORT ID# (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1964581 | RESMED AIR 10 | VENTILATOR, NON-CONTINUOUS (RESPIRATOR) | LRJ | RESMED ASIA PTE. LTD. | 37028 | 1129330 | |
| 1964582 | SOCLEAN 2 | DISINFECTANT, MEDICAL DEVICES | LRJ | SOCLEAN, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Other | AMLODIPINE | DAILY MULTI VITAMIN | LISINOPRIL |