FDA Adverse Event
Malfunction
Summary report: N
AIRFLOW ADULT RESUSCITATION BAG
MDR report key: 3088971
·
Received April 26, 2013
Report
- Report Number
- 3088971
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- April 25, 2013
- Report Date
- April 26, 2013
- Manufacturer
- VENTLAB CORPORATION
- Product Code
- BTM
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT, US
Narratives
Description of Event or Problem · 1
THE DUCK BILL VALVE INSIDE OF THE MANIFOLD DID NOT OPEN WHEN IT WAS SUPPOSED TO. THE RESPIRATORY THERAPIST TESTED THE BAG PRIOR TO USE AND THE VALVE DID NOT OPEN. THE MANAGER OF RESPIRATORY THERAPY DID TRY TO SQUEEZE THE BAG HARDER AND WITH GREATER PRESSURE AND THE VALVE DID OPEN. WE TESTED EVERY ADULT RESUSITATOR WE HAVE AND FOUND 5 BAGS WITH THE SAME PROBLEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?AIRWAY MANAGEMENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181622 | AIRFLOW ADULT RESUSCITATION BAG | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) | BTM | VENTLAB CORPORATION | * | 105588 | |
| 181623 | AIRFLOW ADULT RESUSCITATION BAG | VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) | BTM | VENTLAB CORPORATION | * | 105878 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |