MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-11 for RESMED S8 FLOW GENERATOR HUMIDAIRE S8 ESCAPE * manufactured by Resmed Ltd..
[16259122]
Power supply to resmed s8 flow generator is interrupted during use due to product defect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1042882 |
| MDR Report Key | 852224 |
| Date Received | 2007-05-11 |
| Date of Report | 2007-05-11 |
| Date of Event | 2007-04-01 |
| Date Added to Maude | 2007-05-21 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESMED S8 FLOW GENERATOR |
| Generic Name | CPAP |
| Product Code | NHJ |
| Date Received | 2007-05-11 |
| Model Number | HUMIDAIRE S8 ESCAPE |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 838580 |
| Manufacturer | RESMED LTD. |
| Manufacturer Address | * BELL VISTA NSW AS 2153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-05-11 |