InjuryBTM
AMBU SPUR II ADULT RESUSCITATOR
Received Jan 21, 2022 · Event occurred Jan 14, 2022
Report MW5106892 · MDR key 13334012
Device
Generic name
Ventilator, Emergency, Manual (resuscitator)
Manufacturer
Ambu A/sModel number
PACKAGING UNAVAILABLECatalog number
PACKAGING UNAVAILABLE
Lot number
1000527568
Product problems
- Component Missing
Patient
59 YR · Female
- Low Oxygen Saturation
- Low Oxygen Saturation
Narrative
Description of Event or Problem
PATIENT WAS BEING RESUSCITATED WITH AMBU BAG/MASK PRIOR TO INTUBATION. DUE TO OXYGEN SATURATION LEVELS BEING LOW, A SECOND AMBU WAS OBTAINED. THE PATIENT WAS ADEQUATELY VENTILATED BY THE SECOND AMBU BAG/MASK. UPON INSPECTION OF THE AMBU AFTER THE CODE, IT WAS DISCOVERED THAT THE EXHALATION VALVE WAS MISSING ON THE FIRST AMBU. THIS MISSING VALVE MAY HAVE CONTRIBUTED IN THE LOW SATURATION LEVEL RESULTING FROM INADEQUATE RESUSCITATION. FDA SAFETY REPORT ID# (B)(4).