MalfunctionBTC
SIMS ANESTHESIA BREATHING BAGS
Received Sep 12, 1997 · Event occurred Jul 28, 1997
Report 1044265-1997-00033 · MDR key 120064
Device
Generic name
Anesthesia Breathing Bag
Manufacturer
Sims, Inc.Model number
NACatalog number
321725
Lot number
7F0103
Patient
*
Narrative
Description of Event or Problem
COMPANY'S PRODUCT LABELING AND CLINICAL GUIDELINES REQUIRE TESTING OF THIS DEVICE FOR LEAKS AND BLOCKAGE PRIOR TO USE ON PTS. ACCORDING TO THE COMPLAINANT, LEAKAGE WAS FOUND DURING THE PRE-TEST OF THE ANESTHESIA SYSTEM. AFTER CHECKING THE SYSTEM, SPLIT/CRACK WAS OBSERVED IN THE BREATHING BAG BUSHING. AS THIS INCIDENT OCCURRED AT PRE-TEST STAGE, NO PTS WERE INVOLVED.
Remedial action
- Inspection
- Replace