MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-10 for AIRSENSE 10 AUTOSET USA CO 37207 manufactured by Resmed Ltd.
[185502744]
The device was returned to resmed for an engineering investigation. Initial evaluation determined the device was performing to specifications. Visual inspection revealed thermal damage to the exterior of the device. The investigation methods, results, and conclusion are not finalized at this stage. When more information is available a supplemental report will be submitted. Resmed reference#: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185502745]
It was reported that an airsense 10 device caught fire. It was reported the patient? S son had a minor, small burn on neck due to debris; medical attention was not sought. The device was not in use at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004604967-2020-00349 |
| MDR Report Key | 9814364 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-10 |
| Date Facility Aware | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Date Added to Maude | 2020-03-10 |
| 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 | AIRSENSE 10 AUTOSET USA CO |
| Product Code | BZD |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-18 |
| Model Number | 37207 |
| Catalog Number | 37207 |
| 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 | 2020-03-10 |