MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for ASTRAL 150 DBL KIT - EUR4 27064 manufactured by Resmed Ltd.
[188713325]
The device was received by resmed and an evaluation confirmed the complaint. Visual inspection of the pneumatic block revealed water damage. The pneumatic block was replaced to address the reported problem. The device was serviced and fully tested before it was returned to the customer. Based on all available evidence and complaint investigations of a similar nature, an investigation determined that the reported complaint was due to contamination of the device pneumatic block. Resmed's risk analysis for this failure mode concludes that the risk is acceptable. Resmed reference #: (b)(4). Report late due to transition from vmsr program. Establishment was unaware of fda letter dated 16 september 2019 for cbk procode status change in vmsr program until notified directly by fda on 18 december 2019 following submission of our quarterly summary report.
Patient Sequence No: 1, Text Type: N, H10
[188713326]
It was reported to resmed that an astral device displayed an error message (sf147) related to the main blower. 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 | 3007573469-2020-00174 |
| MDR Report Key | 9583686 |
| Date Received | 2020-01-13 |
| Date of Report | 2020-01-13 |
| Date Facility Aware | 2019-09-15 |
| Report Date | 2020-01-13 |
| Date Reported to FDA | 2020-01-13 |
| Date Reported to Mfgr | 2020-01-13 |
| Date Mfgr Received | 2019-09-15 |
| Date Added to Maude | 2020-01-13 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 DBL KIT - EUR4 |
| Product Code | NOU |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2019-09-15 |
| Model Number | 27064 |
| Catalog Number | 27064 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 15 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 | 2020-01-13 |