MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-03-19 for RESMED S8 AUTOSET VANTAGE manufactured by Resmed Corp.
[17466136]
Client at home preparing for bed, turned machine on to use -not on face at the time. Machine made a noise that per client sounded like an explosion, machine put out a plume of smoke and would not run. Per client, not on his face at the time, no physical damage to his home. The morning of 02. 26. 08, client contacted co for replacement. Per respiratory therapist upon examining bottom of machine it was covered with a black film and it had a "burnt" smell. External cpap case wasn't melted-it was completely intact. Hme working with the mfr to replace all recalled devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005973 |
| MDR Report Key | 1018760 |
| Date Received | 2008-03-19 |
| Date of Report | 2008-03-19 |
| Date of Event | 2008-02-25 |
| Date Added to Maude | 2008-04-01 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESMED S8 AUTOSET VANTAGE |
| Generic Name | CPAP - CONTINOUS POSITIVE AIRWAY PRESSURE MACHINE- |
| Product Code | NHJ |
| Date Received | 2008-03-19 |
| Model Number | S8 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 987172 |
| Manufacturer | RESMED CORP |
| Manufacturer Address | 14040 DANIELSON ST PORWAY CA 920646857 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2008-03-19 |