MalfunctionBYW
RUSCH SILKO REBREATHING BAG, 2.3L
Received Aug 20, 2012
Report 9610520-2012-00012 · MDR key 2712634
Device
Product problems
- Device Displays Incorrect Message
- Device Operates Differently Than Expected
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
THE EVENT IS REPORTED AS: THERE ARE MINIMAL TEARS AT THE JOINT BETWEEN THE HANGER AND THE BAG. DUE TO THE TEAR IN THE BAG, THE BREATHING MACHINE ALARMED. NO PATIENT INJURY REPORTED.
Additional Manufacturer Narrative
THE DEVICE SAMPLE WAS NOT RECEIVED FOR EVALUATION AT THE TIME OF THIS REPORT.