FDA Adverse Event
Malfunction
Summary report: N
S8 ESCAPE - AMERICAS
MDR report key: 1663573
·
Received April 14, 2010
Report
- Report Number
- 3004604967-2010-00018
- Event Type
- Malfunction
- Date Received
- April 14, 2010
- Date of Event
- March 15, 2010
- Report Date
- April 14, 2010
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K033841
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRELIMINARY EXAMINATION OF THIS DEVICE INDICATES THAT THE DEVICE FAILED WITH THE POSSIBILITY OF A BRIEF EXTERNAL FLAME. THERE IS PRELIMINARY EVIDENCE OF FAILURE AROUND THE PSU, AS WELL AS EVIDENCE OF EXTENSIVE WATER CONTAMINATION. THE MANUFACTURER (RESMED LTD) IS CONDUCTING A FULL INVESTIGATION TO DETERMINE THE LIKELY ROOT CAUSE OF THIS FAILURE. THERE WAS NO ADVERSE EVENT REPORTED FOR THIS INCIDENT. THE PT IS CURRENTLY DOING WELL AND HAS NO HEALTH CONCERNS RESULTING FROM THIS INCIDENT. THERE WAS NOT ANY REPORTED DAMAGE TO PERSONAL PROPERTY.
Description of Event or Problem · 1
A PT REPORTED TO THEIR PROVIDER THAT THEIR CPAP UNIT BLEW UP. THE PT WENT TO THEIR DOCTOR FOR SMOKE INHALATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | S8 ESCAPE - AMERICAS | S8 ESCAPE | BZD | RESMED LTD. | 33007 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |