FDA Adverse Event
Injury
Summary report: N
SULLIVAN VPAPII - AUSTRALIA.
MDR report key: 1981045
·
Received February 3, 2011
Report
- Report Number
- 3004604967-2011-00009
- Event Type
- Injury
- Date Received
- February 3, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 3, 2011
- Manufacturer
- RESMED LTD.
- Product Code
- BZD
- PMA / PMN Number
- K961783
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PT WAS KEPT IN THE HOSPITAL OVERNIGHT FOR OBSERVATION. WHILE UNDER OBSERVATION, THE PT WAS ADMINISTERED SOME OXYGEN THERAPY AND DISCHARGED THE NEXT DAY. WITHIN A COUPLE OF DAYS AFTER THE EVENT, THE PT WAS NO LONGER EXPERIENCING ANY CLINICAL SIGNS FROM THIS EVENT. RESMED HAS CONDUCTED AN EVAL OF THE DEVICE. AN INTERNAL INSPECTION FOUND MINOR CHARRING AROUND A FAULTY CAPACITOR ON THE PSU.
Description of Event or Problem · 1
IT WAS REPORTED TO RESMED (B)(4) THAT A VPAP II EMITTED SMOKE WHILE IN USE. THE PT WAS ADMITTED TO HOSPITAL WITH SYMPTOMS OF NAUSEA AND TIGHTENING OF HIS CHEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SULLIVAN VPAPII - AUSTRALIA. | BZD | RESMED LTD. | 21058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |