inforMED
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/s

Catalog 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).