FDA Adverse Event
Malfunction
Summary report: N
ASTRAL 150 - EUR1
MDR report key: 4834247
·
Received June 4, 2015
Report
- Report Number
- 3004604967-2015-00182
- Event Type
- Malfunction
- Date Received
- June 4, 2015
- Manufacturer
- RESMED LTD.
- Product Code
- NOU
- PMA / PMN Number
- K133868
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. (B)(4).
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 363630 | ASTRAL 150 - EUR1 | VENTILATOR, CONTINUOUS (FACILITY/HOME) CBK | NOU | RESMED LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |