ASTRAL 100 - EUR1 Adverse Event — Malfunction (MDR 3004604967-2020-00560)
ASTRAL 100 - EUR1 Adverse Event — Malfunction (MDR 3004604967-2020-00560) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ASTRAL 100 - EUR1; Manufacturer: RESMED LTD; Report number: 3004604967-2020-00560.
| Device | ASTRAL 100 - EUR1 |
|---|---|
| Manufacturer | RESMED LTD |
| Report number | 3004604967-2020-00560 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | FOREIGN |
| Narrative | BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, AN INVESTIGATION DETERMINED THAT THE REPORTED COMPLAINT WAS DUE TO A DESIGN SPECIFICATION LIMITATION. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE #: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →