ASTRAL 100 - AMER Adverse Event — Malfunction (MDR 3007573469-2020-00556)
ASTRAL 100 - AMER Adverse Event — Malfunction (MDR 3007573469-2020-00556) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ASTRAL 100 - AMER; Manufacturer: RESMED LTD; Report number: 3007573469-2020-00556.
| Device | ASTRAL 100 - AMER |
|---|---|
| Manufacturer | RESMED LTD |
| Report number | 3007573469-2020-00556 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Narrative | THE DEVICE WAS RETURNED TO AN AUTHORIZED RESMED THIRD PARTY SERVICE CENTER FOR AN EVALUATION AND SERVICE. THE CUSTOMER WAS ISSUED WITH A REPLACEMENT PNEUMATIC BLOCK ASSEMBLY AS PART OF A WARRANTY CLAIM. RESMED REFERENCE #: (B)(4). |
| Source | openFDA MAUDE (device adverse events) |
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