MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-05 for AIRSENSE 10 AUTOSET USA TRI 37208 manufactured by Resmed Ltd.
[177935135]
Resmed has requested for the device to be returned so that an engineering investigation could be performed. The device has not been returned, therefore, resmed is unable to confirm the alleged malfunction at this time. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177935136]
It was reported to resmed that an airsense 10 device caught fire. There was no patient harm or a serious injury reported as result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007573469-2020-00219 |
| MDR Report Key | 9673950 |
| Date Received | 2020-02-05 |
| Date of Report | 2020-02-05 |
| Date Facility Aware | 2020-01-09 |
| Report Date | 2020-02-05 |
| Date Reported to FDA | 2020-02-05 |
| Date Reported to Mfgr | 2020-02-05 |
| Date Mfgr Received | 2020-01-09 |
| Date Added to Maude | 2020-02-05 |
| 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 | AIRSENSE 10 AUTOSET USA TRI |
| Product Code | BZD |
| Date Received | 2020-02-05 |
| Model Number | 37208 |
| Catalog Number | 37208 |
| Lot Number | 1247647 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 30 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 | 2020-02-05 |