FDA Adverse Event
Malfunction
Summary report: N
TEC 6 NAD VARIANT
MDR report key: 1213194
·
Received October 21, 2008
Report
- Report Number
- 2112667-2008-00043
- Event Type
- Malfunction
- Date Received
- October 21, 2008
- Date of Event
- May 9, 2008
- Report Date
- October 21, 2008
- Manufacturer
- DATEX-OHMEDA
- Product Code
- CAD
- PMA / PMN Number
- K925580
- 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 PATIENT INVOLVEMENT. 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 (B) (6) 1997.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TEC 6 NAD VARIANT | CALIBRATED VAPORIZER | CAD | DATEX-OHMEDA | 1107-9101-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |