FDA Adverse Event
Malfunction
Summary report: N
840
MDR report key: 1963066
·
Received January 11, 2011
Report
- Report Number
- 1963066
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- October 20, 2010
- Report Date
- January 11, 2011
- Manufacturer
- COVIDIEN PURITAN-BENNETT
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
THE VENTILATOR WENT IN-OPERATIVE WHILE CONNECTED TO THE PATIENT. RESPIRATORY WAS CALLED AND THE PATIENT WAS BAGGED WHILE A NEW VENTILATOR WAS PUT ON THE PATIENT.THE VENTILATOR PROVIDES ADEQUATE ANNUNCIATION BOTH AUDIBLY AND VISUALLY WHEN THE VENT GOES IN-OP. ALARM CODES WERE DOWNLOADED BY THE BIOMEDICAL ENGINEERING DEPARTMENT, HOWEVER THEY WERE NOT ABLE TO REPRODUCE THE PROBLEM. THE VENTILATOR PASSED ALL TESTS, WHILE UNDER EVALUATION BY BIOMEDICAL ENGINEERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 | VENTILATOR, CONTINUOUS, FACILITY USE | CBK | COVIDIEN PURITAN-BENNETT | 840 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |