FDA Adverse Event
Malfunction
Summary report: N
HUDSON CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY
MDR report key: 3972823
·
Received April 28, 2014
Report
- Report Number
- 3004365956-2014-00168
- Event Type
- Malfunction
- Date Received
- April 28, 2014
- Date of Event
- April 3, 2014
- Report Date
- April 4, 2014
- Manufacturer
- TELEFLEX
- Product Code
- CAG
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS ON-GOING AT THE TIME OF THIS REPORT. A DHR (DEVICE HISTORY RECORD) REVIEW COULD NOT BE CONDUCTED SINCE THE LOT NUMBER WAS NOT PROVIDED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT CIRCUIT MELTED. THE CIRCUIT SET-UP HAD AN EXTRA PIECE OF NON-HEATED TUBING EXTENDED TO THE PT AND THAT'S WHERE THE TEMPERATURE PROBE SET. THE PT'S OXYGEN SATURATION WAS IN THE 90S. THE CIRCUIT WAS REPLACED. THE CONDITION OF THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253492 | HUDSON CIRCUIT ACCESSORY, HTD WIRE, INSPIRATORY | BREATHING CIRCUIT | CAG | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |