FDA Adverse Event
Malfunction
Summary report: N
S8 COMPACT - AMERICAS
MDR report key: 2940478
·
Received December 20, 2012
Report
- Report Number
- 3004604967-2012-00057
- Event Type
- Malfunction
- Date Received
- December 20, 2012
- Date of Event
- November 20, 2012
- Report Date
- December 20, 2012
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K033841
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A PRELIMINARY EVAL OF THE RETURNED UNIT INDICATED THE POSSIBLE CAUSE OF THE FAILURE AS THE AC APPLIANCE INLET CONNECTOR. THE RESULT OF THIS FAILURE WAS A BRIEF EXTERNAL FLAME THAT SELF ARRESTED AND DID NOT REQUIRE EXTERNAL INTERVENTION. THE DEVICE IS BEING RETURNED TO THE DESIGN FACILITY IN (B)(4), FOR AN ENGINEERING INVESTIGATION TO CONFIRM THE CAUSE OF THE MALFUNCTION. THERE IS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED THAT AN S8 DEVICE CAUGHT ON FIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S8 COMPACT - AMERICAS | BZD | RESMED LTD. | 33030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |