FDA Adverse Event
Malfunction
Summary report: N
HUDSON HEATED WIRE CIRCUIT, ADULT
MDR report key: 4180375
·
Received October 15, 2014
Report
- Report Number
- 3004365956-2014-00373
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 8, 2014
- Report Date
- September 26, 2014
- Manufacturer
- TELEFLEX
- Product Code
- CAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND THERE WERE NO ISSUES FOUND THAT COULD RELATE TO THE REPORTED COMPLAINT. THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO SPECS. THE SAMPLE WAS NOT RETURNED FOR EVAL, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE SAMPLE IS RECEIVED, A F/U REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE CIRCUIT MELTED NEAR THE CUFF PROXIMAL TO THE PT TRACH MASK CONNECTION. NO PT INJURY REPORTED. THE CONDITION OF THE PT IS REPORTED AS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 654276 | HUDSON HEATED WIRE CIRCUIT, ADULT | ADULT BREATHING CIRCUIT | CAG | TELEFLEX | 02J0902058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |