MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2019-08-14 for ASTRAL 100 - APAC2 27082 manufactured by Resmed Ltd.
| Report Number | 3004604967-2019-00258 |
| MDR Report Key | 8895784 |
| Report Source | FOREIGN |
| Date Received | 2019-08-14 |
| Date of Report | 2019-08-15 |
| Date Facility Aware | 2019-07-19 |
| Date Mfgr Received | 2019-07-19 |
| Date Added to Maude | 2019-08-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MICHELLE HUGHES |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA |
| Manufacturer City | SYDNEY, NSW 2153 |
| Manufacturer Country | AU |
| Manufacturer Postal | 2153 |
| Manufacturer G1 | RESMED LTD |
| Manufacturer Street | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA |
| Manufacturer City | SYDNEY, NSW 2153 |
| Manufacturer Country | AU |
| Manufacturer Postal Code | 2153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTRAL 100 - APAC2 |
| Product Code | NOU |
| Date Received | 2019-08-14 |
| Model Number | 27082 |
| Catalog Number | 27082 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-14 |