FDA Adverse Event
Malfunction
Summary report: N
TEC 6
MDR report key: 1111935
·
Received August 11, 2008
Report
- Report Number
- 2112667-2008-00033
- Event Type
- Malfunction
- Date Received
- August 11, 2008
- Date of Event
- May 22, 2008
- Report Date
- August 11, 2008
- Manufacturer
- DATEX-OHMEDA
- Product Code
- CAD
- PMA / PMN Number
- K000275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION/CONCLUSION: THE UNIT WAS RETURNED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE UNIT WAS TESTED AND THE REPORTED COMPLAINT WAS CONFIRMED. THE INVESTIGATION HAS CONCLUDED THAT THE CAUSE OF THE REPORTED COMPLAINT WAS DUE TO SCRATCHING AND/OR FLATNESS ISSUES RELATED TO THE SEALING FACE OF THE ROTARY VALVE. CHANGES IN MANUFACTURING PROCESSES HAVE GREATLY REDUCED THESE ISSUES. CHANGES WERE IMPLEMENTED INTO THE MANUFACTURING, REFURBISHING AND SERVICE PROCESSES IN 1997.
Description of Event or Problem · 1
CUSTOMER REPORTED THEY FELT THE OUTPUT OF THEIR VAPORIZER WAS HIGHER THAN EXPECTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
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 |