FDA Adverse Event
Other
Summary report: N
VENTILATOR, CONTINUOUS, FACILITY USE
MDR report key: 2163595
·
Received June 6, 2011
Report
- Report Number
- 2518422-2011-00060
- Event Type
- Other
- Date Received
- June 6, 2011
- Date of Event
- March 31, 2011
- Report Date
- May 9, 2011
- Manufacturer
- RESPIRONICS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE MFR RECEIVED INFO ALLEGING A PT'S BLOOD OXYGEN SATURATION DECREASED WHEN A VENTILATOR THAT WAS PROVIDING THERAPY DID NOT DELIVER THE SET NUMBER OF BREATHS. THE PT WAS PLACED ON ANOTHER DEVICE AND THERE WAS NO REPORTED SERIOUS HARM OR INJURY. THE MFR'S INVESTIGATION IS CURRENTLY ONGOING, AND A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTILATOR, CONTINUOUS, FACILITY USE | TRILOGY 100 | CBK | RESPIRONICS, INC. | 1054260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |