FDA Adverse Event
Malfunction
Summary report: N
S8 AUTOSET VANTAGE - AMERICAS
MDR report key: 2305125
·
Received September 22, 2011
Report
- Report Number
- 3004604967-2011-00049
- Event Type
- Malfunction
- Date Received
- September 22, 2011
- Date of Event
- August 1, 2011
- Report Date
- September 22, 2011
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K041209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. THE DEVICE IN QUESTION HAS NOT BEEN RETURNED. HOWEVER, RESMED HAS MADE REQUESTS FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. AS THIS HAS NOT OCCURRED, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED THAT AN S8 VANTAGE DEVICE CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S8 AUTOSET VANTAGE - AMERICAS | BZD | RESMED LTD. | 33112 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |