ASTRAL 150 - AMER Adverse Event — Malfunction (MDR 3004604967-2020-00554)
ASTRAL 150 - AMER Adverse Event — Malfunction (MDR 3004604967-2020-00554) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ASTRAL 150 - AMER; Manufacturer: RESMED LTD; Report number: 3004604967-2020-00554.
| Device | ASTRAL 150 - AMER |
|---|---|
| Manufacturer | RESMED LTD |
| Report number | 3004604967-2020-00554 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | DISTRIBUTOR |
| Narrative | THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. PERFORMANCE TESTING CONFIRMED THE REPORTED COMPLAINT. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THE REPORTED COMPLAINT AND REVEALED AN ERROR MESSAGE (SF180) RELATED TO A BATTERY CHARGER FAULT. THE INTERNAL BATTERY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. BASED ON |
| Source | openFDA MAUDE (device adverse events) |
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