MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-09 for ASTRAL 150 - FUKUDA 27093 manufactured by Resmed Ltd.
[188559482]
The astral device was returned to resmed for an investigation. Performance testing and review of the device data logs confirmed the reported complaint. The investigation determined that the reported event was due to an abnormally long stabilization period of inspiratory flow sensor component after production. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. Resmed reference #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[188559483]
It was reported to resmed that an astral device failed to complete its internal self-test. There was no patient harm or serious injury reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007573469-2020-00040 |
| MDR Report Key | 9572325 |
| Date Received | 2020-01-09 |
| Date of Report | 2020-01-09 |
| Date Facility Aware | 2019-12-17 |
| Report Date | 2020-01-09 |
| Date Reported to FDA | 2020-01-09 |
| Date Reported to Mfgr | 2020-01-09 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-09 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASTRAL 150 - FUKUDA |
| Product Code | NOU |
| Date Received | 2020-01-09 |
| Model Number | 27093 |
| Catalog Number | 27093 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 12 MO |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-09 |