FDA Adverse Event
Summary report: N
AIRFLOW ADULT/PEDIATRIC RESUSCITATOR
MDR report key: 1582406
·
Received December 18, 2009
Report
- Report Number
- 1582406
- Date Received
- December 18, 2009
- Date of Event
- January 1, 2009
- Report Date
- December 18, 2009
- Manufacturer
- VENTLAB CORPORATION
- Product Code
- BTM
- Report Source
- User Facility report
- Reporter Location
- WV, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
IT HAS BEEN IDENTIFIED THAT CONFUSION IS MORE LIKELY TO EXIST IN AN EMERGENCY SITUATION DUE TO THE IDENTIFICATION/LABELING OF THE AIRFLOW PEDIATRIC RESUSCITATOR AND THE AIRFLOW ADULT RESUSCITATOR. BOTH ARE THE SAME COLOR GREEN; HOWEVER, THE ADULT ONE IS CONTAINED IN A PLASTIC BAG WITH THE WORD ADULT PRINTED IN THE MIDDLE OF A 1/2 INCH BLUE STRIPE AT THE BOTTOM OF THE BAG. THE PEDIATRIC ONE IS IN A PLASTIC BAG WITH THE WORD PEDIATRIC PRINTED IN THE MIDDLE OF A 1/2 INCH YELLOW STRIPE AT THE BOTTOM OF THE BAG. QUESTION IF DIFFERENT COLOR BAGS COULD BE USED DUE TO LIKELIHOOD OF CONFUSION IN AN EMERGENCY SITUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AIRFLOW ADULT/PEDIATRIC RESUSCITATOR | RESUSCITATORS | BTM | VENTLAB CORPORATION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |