MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-02-13 for BATTERIE EXTERNE ASTRAL 27918 manufactured by Resmed Ltd.
[187421291]
The device was returned and an evaluation confirmed the complaint. The customer declined service and the external battery was scrapped. Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to a defective external battery. Resmed's risk analysis for these failure modes concludes that the risk is acceptable. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[187421292]
It was reported to resmed that an astral device had an external battery with reduced level of capacity. 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 | 3004604967-2020-00246 |
| MDR Report Key | 9708967 |
| Report Source | FOREIGN |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-13 |
| Date Facility Aware | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| 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 | BATTERIE EXTERNE ASTRAL |
| Product Code | NOU |
| Date Received | 2020-02-13 |
| Returned To Mfg | 2019-09-10 |
| Model Number | 27918 |
| Catalog Number | 27918 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 | 2020-02-13 |