FDA Adverse Event
Summary report: N
LIFE PULSE
MDR report key: 2154907
·
Received July 1, 2011
Report
- Report Number
- 2154907
- Date Received
- July 1, 2011
- Date of Event
- June 25, 2011
- Report Date
- July 1, 2011
- Manufacturer
- BUNNELL, INC.
- Product Code
- LSZ
- Report Source
- User Facility report
- Reporter Location
- PA, US
Narratives
Description of Event or Problem · 1
JET VENTILATOR INITIATED ON PATIENT. ON INITIAL SET-UP, VENTILATOR WAS CONNECTED DIRECTLY TO WALL OXYGEN LINE INSTEAD OF A LOW FLOW BLENDER. THEREFORE, PATIENT WAS RECEIVING A HIGHER CONCENTRATION OF OXYGEN. SEVERAL DAYS AFTER THE INITIAL ADMINISTRATION OF JET VENTILATION THERAPY, EVENT WAS DISCOVERED AND CORRECTED. CONVENTIONAL VENTILATORS HAVE A BLENDER BUILT IN. THE JET VENTILATOR DOES NOT AND REQUIRES THE THERAPIST TO ADD TO THE DEVICE. IN THE CASE OF THIS EVENT, THIS STEP WAS OMITTED ON INITIAL SET-UP. IN THIS EVENT, JET WAS DELIVERING 100% CONCENTRATION OF OXYGEN AND CONVENTIONAL VENTILATOR WAS DELIVERING 21%.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFE PULSE | VENTILATOR, HIGH FREQUENCY | LSZ | BUNNELL, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 DAY | NO OTHER THERAPIES |