FDA Adverse Event
Malfunction
Summary report: N
HUDSON ADULT HEATED WIRE CIRCUIT
MDR report key: 1970901
·
Received January 4, 2011
Report
- Report Number
- 3004365956-2011-00013
- Event Type
- Malfunction
- Date Received
- January 4, 2011
- Date of Event
- December 9, 2010
- Report Date
- December 10, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BZO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CIRCUIT WAS SET UP AND CONNECTED TO THE PATIENT'S NIV MASK. A TELEFLEX CONCHA NEPTUNE HEATER WAS TURNED ON TO SUPPLY HEATED RESPIRATORY SUPPORT. THE CIRCUIT WAS IN USE FOR 24 HOURS BEFORE IT WAS FOUND TO HAVE MELTED AT THE COLUMN END CONNECTOR. NO PATIENT INJURY OR INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON ADULT HEATED WIRE CIRCUIT | VENTILATOR CIRCUIT | BZO | TELEFLEX MEDICAL | NA | 02M0900960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |