FDA Adverse Event
Malfunction
Summary report: N
HUDSON HEATED WIRE VENTILATOR CIRCUIT
MDR report key: 1933871
·
Received December 7, 2010
Report
- Report Number
- 3004365956-2010-00350
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Report Date
- November 16, 2010
- Manufacturer
- TELEFLEX MEDICAL
- Product Code
- BZO
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT HAS BEEN RECEIVED BY MFR FOR EVAL, HOWEVER, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.
Description of Event or Problem · 1
THE EVENT IS REPORTED AS: THE CIRCUIT MELTED WHILE ON A TRACH PT. THE CIRCUIT WAS BEING USED WHILE HEATED HUMIDIFICATION WAS BEING ADMINISTERED. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON HEATED WIRE VENTILATOR CIRCUIT | VENTILATOR CIRCUIT | BZO | TELEFLEX MEDICAL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |