FDA Adverse Event
Summary report: N
HUDSON RCI ADULT VENTILATOR CIRCUITS, HEATED-WIRES
MDR report key: 1860827
·
Received October 1, 2010
Report
- Report Number
- 1860827
- Date Received
- October 1, 2010
- Date of Event
- July 26, 2010
- Report Date
- September 30, 2010
- Manufacturer
- ARROW INTERNATIONAL TELEFLEX
- Product Code
- BZO
- Report Source
- User Facility report
- Reporter Location
- OR, US
Narratives
Description of Event or Problem · 1
VENTILATOR TUBING BECAME HOT AND MELTED. PATIENT DID NOT GET APPROPRIATE HUMIDIFICATION. THIS HAS HAPPENED NOW ON TWO SEPARATE OCCASIONS.======================HEALTH PROFESSIONAL'S IMPRESSION======================VENTILATOR TUBING COULD HAVE GOTTEN HOT ENOUGH TO IGNITE AND CAUSE A FIRE.======================MANUFACTURER RESPONSE FOR VENTILATOR TUBING, HUDSON RCI HEATED WIRE BREATHING CIRCUIT======================NOT AWARE OF ANY RESPONSE. THEY WERE SUPPOSED TO MEET WITH OUR RESPIRATORY MANAGER TODAY BUT DID NOT SHOW UP FOR THE MEETING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HUDSON RCI ADULT VENTILATOR CIRCUITS, HEATED-WIRES | SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) | BZO | ARROW INTERNATIONAL TELEFLEX | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |