FDA Adverse Event
Other
Summary report: N
VPAP QUICKNAV - EUR GP2
MDR report key: 2507478
·
Received March 13, 2012
Report
- Report Number
- 3004604967-2012-00009
- Event Type
- Other
- Date Received
- March 13, 2012
- Date of Event
- February 1, 2012
- Report Date
- March 13, 2012
- Manufacturer
- RESMED LTD.
- Product Code
- MNS
- PMA / PMN Number
- K060105
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESMED HAS MADE REQUESTS FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. AS THIS HAS NOT OCCURRED, RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME.
Description of Event or Problem · 1
PT AT (B)(6) WAS FOUND OUT OF BREATH AFTER BEING TREATED WITH VPAP III ST-A QN. CPR WAS ADMINISTERED TO THE PT AND THE PT SURVIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VPAP QUICKNAV - EUR GP2 | MNS | RESMED LTD. | 24135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |