MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-15 for RESMED AIR SENSE S 10 AUTOSET CPAP MACHINE 37207 37051 manufactured by Resmed Ltd..
[175699420]
Hello, i use a resmed air sense s10 autoset auto - cpap machine with humidair, heated humidifier when the water chamber runs out of still water. The unit still heats the plastic water chamber casing smells and toxins into your air ways. Breathing in toxins from plastic. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092302 |
| MDR Report Key | 9596298 |
| Date Received | 2020-01-15 |
| Date of Report | 2020-01-14 |
| Date of Event | 2019-12-14 |
| Date Added to Maude | 2020-01-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| 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 | RESMED AIR SENSE S 10 AUTOSET CPAP MACHINE |
| Generic Name | VENTILATOR NON-CONTINUOUS RESPIRATOR |
| Product Code | BZD |
| Date Received | 2020-01-15 |
| Model Number | 37207 |
| Catalog Number | 37051 |
| Lot Number | 1411827 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESMED LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-15 |