FDA Adverse Event
Malfunction
Summary report: N
S8 AUTOSET VANTAGE - AMERICAS
MDR report key: 2881196
·
Received November 15, 2012
Report
- Report Number
- 3004604967-2012-00045
- Event Type
- Malfunction
- Date Received
- November 15, 2012
- Date of Event
- October 18, 2012
- Report Date
- November 15, 2012
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K041209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ENGINEERING INVESTIGATION OF THE RETURNED UNIT IDENTIFIED THE ROOT 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. THERE IS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED THAT AN S8 AUTOSET VANTAGE POWER SUPPLY BURNED.
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 |