MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-04-05 for RESMED S8 S8 ESCAPE * manufactured by Resmed Corp..
[601872]
Pt was wearing resmed s8 cpap machine. He smelled smoke through mask. Upon inspection by pt, saw machine was sparking out backside. Machine then caught fire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042487 |
| MDR Report Key | 836003 |
| Date Received | 2007-04-05 |
| Date of Report | 2007-04-05 |
| Date of Event | 2007-03-26 |
| Date Added to Maude | 2007-04-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESMED S8 |
| Generic Name | CPAP MACHINE |
| Product Code | NHJ |
| Date Received | 2007-04-05 |
| Returned To Mfg | 2007-04-05 |
| Model Number | S8 ESCAPE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 823295 |
| Manufacturer | RESMED CORP. |
| Manufacturer Address | LOCKBOX 51054 LOS ANGELES CA 900515354 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-04-05 |