FDA Adverse Event
Malfunction
Summary report: N
HEATED WIRE BREATHING CIRCUIT
MDR report key: 2121719
·
Received May 19, 2011
Report
- Report Number
- 3004365956-2011-00213
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- April 28, 2011
- Report Date
- May 2, 2011
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- CAI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO SAMPLE IS AVAILABLE FOR THE MFR TO EVALUATE. A FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: COMPLAINT ALLEGES THAT DURING MECHANICAL VENTILATION; A BURNED HOLE WAS FOUND IN THE HUDSON 780-98 NIV HEATED WIRE CIRCUIT. COMPLAINT INDICATES THAT THE RESPIRATORY THERAPIST FORGOT TO TURN OFF THE HEATER AFTER TURNING OFF THE VENTILATOR. THE ALLEGED BURN HOLE WAS FOUND IN THE PROXIMAL PART OF THE CIRCUIT. THERE WERE NO PT INJURIES AS THE PT WAS OFF THE VENTILATOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HEATED WIRE BREATHING CIRCUIT | BREATHING CIRCUIT | CAI | TELEFLEX MEDICAL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | HUDSON CONCHATHERM NEPTUNE HEATED HUMIDIFIER,| 425-00 |