ASTRAL 150 - FUKUDA Adverse Event — Malfunction (MDR 3007573469-2020-00558)
ASTRAL 150 - FUKUDA Adverse Event — Malfunction (MDR 3007573469-2020-00558) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ASTRAL 150 - FUKUDA; Manufacturer: RESMED LTD; Report number: 3007573469-2020-00558.
| Device | ASTRAL 150 - FUKUDA |
|---|---|
| Manufacturer | RESMED LTD |
| Report number | 3007573469-2020-00558 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | THE DEVICE WAS RETURNED TO RESMED AND AN EVALUATION CONFIRMED THE COMPLAINT. THE NON-RETURN VALVE (NRV) ASSEMBLY WAS REPLACED TO ADDRESS THIS ISSUE. THE DEVICE WAS SERVICED AND FULLY TESTED BEFORE IT WAS RETURNED TO THE CUSTOMER. RESMED REFERENCE#: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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