MalfunctionBTM
AIRFLOW SMALL ADULT RESUSCITATOR
Received Apr 2, 2013
Report 2246980-2013-00003 · MDR key 3212895
Device
Generic name
Ventilator, Emergency, Manual (resus)
Manufacturer
Ventlab LlcModel number
AF5040MBLot number
105181
Product problems
- Deflation Problem
- Disconnection
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
WHEN USING THE AMBU BAG ON A PT, IT WAS DISCOVERED THAT THE RESERVOIR BAG WAS DEFLATED AND UPON FURTHER INSPECTION IT WAS DETERMINED THE TUBING FROM THE OXYGEN SOURCE WAS NOT CONNECTED TO THE AMBU BAG.
Additional Manufacturer Narrative
METHOD/RESULTS: PRODUCT NOT RETURNED FOR EVAL. ENGINEERING PERFORMING TOLERANCE STACK-UP.