ASTRAL 150 - FUKUDA Adverse Event — Malfunction (MDR 3007573469-2020-00559)
ASTRAL 150 - FUKUDA Adverse Event — Malfunction (MDR 3007573469-2020-00559) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ASTRAL 150 - FUKUDA; Manufacturer: RESMED LTD; Report number: 3007573469-2020-00559.
| Device | ASTRAL 150 - FUKUDA |
|---|---|
| Manufacturer | RESMED LTD |
| Report number | 3007573469-2020-00559 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | THE ASTRAL DEVICE WAS RETURNED TO RESMED FOR AN INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED AN INTERNAL BATTERY DEGRADED WARNING ALARM AND REVEALED AN ERROR MESSAGE (SF180) RELATED TO A BATTERY CHARGER FAULT. THE INTERNAL BATTERY WAS REPLACED TO ADDRESS THE ISSUE. BASED ON ALL AVAILABLE EVIDENCE AND COMPLAINT INVESTIGATIONS OF A SIMILAR NATURE, THE INVESTIGATION DETERMINED THAT THE REP |
| Source | openFDA MAUDE (device adverse events) |
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