FDA Adverse Event
Malfunction
Summary report: N
S8 ELITE- AMERICAS
MDR report key: 1122211
·
Received August 15, 2008
Report
- Report Number
- 3004604967-2008-00011
- Event Type
- Malfunction
- Date Received
- August 15, 2008
- Date of Event
- June 26, 2008
- Report Date
- August 14, 2008
- Product Code
- BZD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHORTING IN THE POWER SUPPLY MODULE CAUSED THERMAL DAMAGE WITH SOME EVIDENCE OF EXTERNAL FLAME.
Description of Event or Problem · 1
(B) (6) INFORMED (B) (4) (RESMED TERRITORY MANAGER) THAT THEIR CUSTOMER TOLD THEM THAT HE FIRST SMELLED SMOKE FROM HIS UNIT. AND WHEN HE OPERATED THE UNIT, THE UNIT CAUGHT FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S8 ELITE- AMERICAS | S8 ELITE- AMERICAS | BZD | 33021 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |