FDA Adverse Event
Malfunction
Summary report: N
TEC 6
MDR report key: 1030448
·
Received April 16, 2008
Report
- Report Number
- 2112667-2008-00015
- Event Type
- Malfunction
- Date Received
- April 16, 2008
- Date of Event
- January 22, 2008
- Report Date
- April 16, 2008
- Manufacturer
- DATEX-OHMEDA
- Product Code
- CAD
- PMA / PMN Number
- K913593
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THE VAPORIZER WAS NOT ACCURATE. THERE WAS NO REPORT OF PT INVOLVEMENT. INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND THE REPORTED COMPLAINT WAS CONFIRMED. PAST INVESTIGATIONS OF SIMILAR INSTANCES DETERMINED THAT THE ROTARY VALVES WERE SUBJECT TO SCRATCHING OR INCORRECT GEOMETRY (FLATNESS) OF ITS SEALING FACE. CHANGES WERE IMPLEMENTED IN 1997 IN WHICH GRAPHITE WAS ADDED TO THE FACE OF THESE COMPONENTS FOR NEW MANUFACTURED VAPORIZERS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEC 6 | CALIBRATED VAPORIZER | CAD | DATEX-OHMEDA | 1107-9001-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |