ADULT BREATHING CIRCUIT DUAL HEATED
Report
- Report Number
- 9611451-2007-00213
- Event Type
- Malfunction
- Date Received
- June 15, 2007
- Report Date
- May 10, 2007
- Manufacturer
- FISHER & PAYKEL HEALTHCARE, LTD.
- Product Code
- BTT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER AND PAYKEL HEALTHCARE. THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) FOR THAT PRODUCT IS K903112. THE FAULTY PRODUCT WAS VISUALLY INSPECTED. ONE HEATER WIRE PIN ON THE EXPIRATORY SIDE WAS BENT, MAKING IT IMPOSSIBLE TO CONNECT THE ELECTRICAL ADAPTOR TO THE BREATHING CIRCUIT. IF THE PINS HAD BEEN BENT RIGHT OVER DURING MANUFACTURING, THEY WOULD HAVE BEEN DETECTED DURING OUR ELECTRICAL TESTS AND VISUAL INSPECTIONS. WE BELIEVE THAT THE BENDING OBSERVED OCCURRED WHEN THE HEATER WIRE ADAPTOR WAS BEING CONNECTED DURING BREATHING CIRCUIT SET-UP. THE DEVICE FAILED JUST PRIOR TO USE. THE RATE OF OCCURRENCE FOR SUCH COMPLAINTS IS APPROXIMATELY 0.0011 WORLDWIDE FOR THE LAST YEAR. THE FOLLOWING MDR NUMBER ARE RELATED: 9611451-2007-00013, 9611451-2007-00052, 9611451-2007-00195, 9611451-2007-00215, 9611451-2007-00017, 9611451-2007-00044, 9611451-2007-00202, 9611451-2007-00214. A BENT HEATER WIRE PIN THE HEATED BREATHING CIRCUIT UNUSABLE AS THE HEATER WIRE ADAPTER CANNOT BE CONNECTED. THIS WOULD BE IDENTIFIED AT SET UP.
REPORTER REPORTED THAT THEY FOUND IT IMPOSSIBLE TO CONNECT THE ELECTRICAL ADAPTER TO THE RT204 BREATHING CIRCUIT BECAUSE THE PIN FOR THE HEATER WIRE WAS BENT (EXPIRATORY SIDE ).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADULT BREATHING CIRCUIT DUAL HEATED | BTT | FISHER & PAYKEL HEALTHCARE, LTD. | RT204 | 060920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |