FDA Adverse Event
Other
Summary report: N
VENTILATOR, CONTINUOUS, FACILITY USE
MDR report key: 2358014
·
Received November 30, 2011
Report
- Report Number
- 2518422-2011-00178
- Event Type
- Other
- Date Received
- November 30, 2011
- Date of Event
- November 3, 2011
- Report Date
- November 3, 2011
- Manufacturer
- RESPIRONICS INC.
- Product Code
- CBK
- PMA / PMN Number
- K083526
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE MFR RECEIVED INFO ALLEGING A VENTILATOR FAILED TO AUDIBLY ALARM WHEN A PT PULLED HIS TRACHEOSTOMY TUBE OUT. A CAREGIVER WITNESSED THE EVENT AND INTERVENED. THERE WAS NO PT HARM OR INJURY. THE MFR'S INVESTIGATION OF THIS REPORTED EVENT IS CURRENTLY ON-GOING. A FOLLOW-UP 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 | 1 YR | Required Intervention |