MalfunctionBTM
SPUR® II ADULT RESUSCITATORSINGLE PATIENT USE RESUSCITATOR
Received Nov 1, 2021 · Event occurred Oct 15, 2021
Report 12727447 · MDR key 12727447
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Model number
520211010Catalog number
520211010
Lot number
1000502949
Product problems
- Fluid/Blood Leak
Patient
21900 DA
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
WHILE PREPARING TO INTUBATE A PATIENT, O2 SATURATIONS WERE NOTED TO BE DECREASING. ASSESSMENT BY BEDSIDE PERSONNEL (NURSING, RESPIRATORY, AND DOCTOR) FOUND AMBU (SPUR® II ADULT RESUSCITATOR) BAG WAS FOUND TO BE LEAKING. DEVICE SWITCHED OUT WITH RAPID IMPROVEMENT IN OXYGEN SATURATION.