MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for AIRSENSE 10 AUTOSET USA TRI 37208 manufactured by Resmed Ltd.
[180109534]
The device was returned to resmed for an engineering investigation. The investigation methods, results and conclusion are not finalized at this stage. When more information is available, a supplemental report will be submitted. (b)(4). Pending evaluation.
Patient Sequence No: 1, Text Type: N, H10
[180109535]
It was allegedly reported to resmed that an airsense 10 device caught fire. There was no patient harm or a serious injury reported as a result of this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007573469-2020-00259 |
| MDR Report Key | 9729992 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-19 |
| Date Facility Aware | 2020-01-20 |
| Report Date | 2020-02-19 |
| Date Reported to FDA | 2020-02-19 |
| Date Reported to Mfgr | 2020-02-19 |
| Date Mfgr Received | 2020-01-20 |
| Date Added to Maude | 2020-02-19 |
| 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 | AIRSENSE 10 AUTOSET USA TRI |
| Product Code | BZD |
| Date Received | 2020-02-19 |
| Returned To Mfg | 2020-01-27 |
| Model Number | 37208 |
| Catalog Number | 37208 |
| Lot Number | 1247647 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 30 MO |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-02-19 |