FDA Adverse Event
Malfunction
Summary report: N
AIRLIFE DUAL AIR VENTURI MASKS
MDR report key: 1102803
·
Received July 21, 2008
Report
- Report Number
- 1102803
- Event Type
- Malfunction
- Date Received
- July 21, 2008
- Date of Event
- June 4, 2008
- Report Date
- July 21, 2008
- Manufacturer
- CARDINAL HEALTH
- Product Code
- BYG
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- KY, US
Narratives
Description of Event or Problem · 1
PATIENT WAS ON VENTURI MASK SET FOR FIO2 OF 50%; MASK NOT DELIVERING SET AMOUNT OF O2 AND PATIENT SATS DROPPED TO LOW 80'S. FLOW METERS DISCHARGED OUT, RAN OFF A TANK, AND VERIFIED WITH AN ANALYZER, WITH THE WHITE ENTRAINMENT DEVICE. THE HIGHEST FIO2 ANALYZED WAS 25%. THE STAFF THEN PLACED ON 31% WITH THE BLUE ENTRAINMENT DEVICE AND THE HIGHEST FIO2 ANALYZED WAS 25%. STAFF TRIED 3 DIFFERENT VENTURI DEVICES OF THE SAME BRAND WITH THE SAME RESULTS. EVERY PATIENT IN THE HOSPITAL CHECKED TO SEE IF USING THIS DEVICE; NONE FOUND IN USE ELSEWHERE. VENTURI MASKS REMOVED FROM USE IN ENTIRE FACILITY, PENDING RESOLUTION BY MATERIALS MANAGEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIRLIFE DUAL AIR VENTURI MASKS | MASK, OXYGEN | BYG | CARDINAL HEALTH | * | Y08BO573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |