MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-22 for ASTRAL 100 - APAC1 27081 manufactured by Resmed Ltd.
[95922436]
The device was not returned to resmed for an evaluation. The power supply unit (psu) was confirmed to be defective by the medical service provider. The psu was replaced to address this issue. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. The reportable event occurred outside the us. During a routine check of complaints records it was detected that the event is reportable in the us. This report is being submitted to correct the error. Resmed reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[95922437]
It was reported to resmed that an astral power supply unit (psu) was not providing power. There was no patient injury reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2017-01863 |
| MDR Report Key | 7145055 |
| Date Received | 2017-12-22 |
| Date of Report | 2017-12-22 |
| Date Facility Aware | 2017-08-31 |
| Date Mfgr Received | 2017-08-31 |
| Date Added to Maude | 2017-12-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MR. DAVID DULEY |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal | 92123 |
| Manufacturer G1 | RESMED CORP |
| Manufacturer Street | 9001 SPECTRUM CENTER BLVD |
| Manufacturer City | SAN DIEGO CA 92123 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92123 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ASTRAL 100 - APAC1 |
| Product Code | CBK |
| Date Received | 2017-12-22 |
| Model Number | 27081 |
| Catalog Number | 27081 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 18 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD |
| Manufacturer Address | 1 ELIZABETH MACARTHUR DRIVE. BELLA VISTA SYDNEY, NSW 2153 AU 2153 |
| Brand Name | ASTRAL 100 - APAC1 |
| Product Code | OIM |
| Date Received | 2017-12-22 |
| Model Number | 27081 |
| Catalog Number | 27081 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 18 MO |
| 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 | 2017-12-22 |