LAERDAL DISPOSABLE PEEP VALVE ASSEMBLY
Received Jul 16, 2015 · Event occurred May 1, 2015
Report 9610483-2015-00001 · MDR key 4926063
Device
Product problems
- Complete Blockage
- Use of Device Problem
- Device Handling Problem
Patient
Not reported
- Respiratory Distress
- Obstruction/Occlusion
Narrative
Additional Manufacturer Narrative
FOLLOWING THIS EVENT THE USER INSPECTED THE EQUIPMENT AND FOUND THE PEEP VALVE WAS STUCK/CLOGGED WITH PATIENT SECRETIONS. THEY DISPOSED OF THIS VALVE AND IT WAS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. THIS LSR AND PEEP VALVE HAD BEEN USED REPEATEDLY ON THIS ONE PATIENT THROUGHOUT THE WEEK. THEY DID NOT REPORT DOING ANY PRE-USE FUNCTIONAL TESTING OF THE LSR AND/OR PEEP DURING THIS WEEK. THE PEEP VALVE IS LABELED AS A SINGLE PATIENT USE PRODUCT. NO CORRECTIVE ACTION IS RECOMMENDED.
Description of Event or Problem
LAERDAL MEDICAL (B)(4) HAS INFORMED LAERDAL MEDICAL CORPORATION (LMC) IN (B)(4) OF AN EVENT WHICH OCCURRED IN (B)(6). IN (B)(6) 2015 A MALE PATIENT WITH PNEUMONIA, WHO HAD BEEN IN THE HOSPITAL 6-7 DAYS, WAS INTUBATED AND HAD BEEN MECHANICALLY VENTILATED WHEN THEY WERE TO BE MANUALLY VENTILATED WITH A LAERDAL SILICON RESUSCITATOR (LSR) AND PEEP VALVE. THE LSR WAS USED AND THE NURSE NOTICED THE PATIENT WAS NOT EXHALING AND THEY PROMPTLY REMOVED THE LSR AND USED OTHER VENTILATION. THIS LSR W/PEEP VALVE HAD BEEN USED ON THIS PATIENT OFF AND ON FOR THE ENTIRE WEEK. THE PATIENT WAS NOT HARMED DURING THIS EVENT. THE PATIENT'S FINAL OUTCOME IS UNKNOWN.