MalfunctionCAE
AMBU AURASTRAIGHT SILICONE
Received Nov 13, 2019 · Event occurred Sep 27, 2019
Report 9314545 · MDR key 9314545
Device
Generic name
Airway, Oropharyngeal, Anesthesiology
Manufacturer
Besmed Health Business CorporationModel number
342300000, 342500000, 342400000Product problems
- Difficult to Insert
Patient
18980 DA
- No Code Available
- No Code Available
Narrative
Description of Event or Problem
ANESTHESIOLOGIST ATTEMPTED TO PLACE LARYNGEAL MASK AIRWAY (LMA) X3 (AMBU AURASTRAIGHT SILICONE SINGLE USE LARYNGEAL MASK) WITH DIFFICULTY AND WITHOUT SUCCESS. LMA OF VARIOUS SIZES WOULD NOT GO DOWN OR STAY IN THE PROPER PLACE. PATIENT HAD MODERATE BLOODY SECRETIONS. ANESTHESIA'S PLAN FOR GENERAL ANESTHESIA CONVERTED TO MONITORED ANESTHESIA CARE. MAC SEDATION USED FOR PROCEDURE INSTEAD OF PLANNED GENERAL ANESTHESIA.