FDA Adverse Event
Injury
Summary report: N
AIRSENSE 10 CPAP USA CO
MDR report key: 12662681
·
Received October 19, 2021
Report
- Report Number
- 3004604967-2021-01086
- Event Type
- Injury
- Date Received
- October 19, 2021
- Date of Event
- August 12, 2021
- Report Date
- October 19, 2021
- Manufacturer
- RESMED LTD
- Product Code
- BZD
- UDI-DI
- 00619498372119
- PMA / PMN Number
- K140124
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE # (B)(4). MEDWATCH REPORT# 5103682.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED THAT THE PRESSURE DELIVERED FROM AN AIRSENSE 10 CPAP WAS GREATER THAN 30 PSI. SERIOUS INJURY WITH REQUIRED INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1559492 | AIRSENSE 10 CPAP USA CO | BZD | RESMED LTD | 37203 | 00619498372119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |