RESUSCITATOR,ADLT,MASK,TUB RES

Description of Event or Problem

DURING A RESUSCITATION ATTEMPT INVOLVING AN ADULT MALE PATIENT, THE MEDLINE RESUSCITATION BAG REPORTEDLY FAILED TO ADEQUATELY VENTILATE THE PATIENT. THE PATIENT EXPERIENCED DESATURATION AND DID NOT IMPROVE WHILE THE MEDLINE DEVICE WAS IN USE. UPON SWITCHING TO A PREVIOUSLY STOCKED RESUSCITATION BAG FROM ANOTHER BRAND, VENTILATION IMPROVED AND THE PATIENT'S OXYGEN SATURATION INCREASED. THE FACILITY REPORTED PROBLEMS WITH ADEQUATE DELIVERY OF POSITIVE PRESSURE WHEN THE BAG IS NOT HELD PERFECTLY STRAIGHT, AS PRESSURE IS LOST WHEN TORQUE IS APPLIED AT THE JUNCTION TO THE ADAPTER.

Additional Manufacturer Narrative

DURING A RESUSCITATION ATTEMPT INVOLVING AN ADULT MALE PATIENT, THE MEDLINE RESUSCITATION BAG REPORTEDLY FAILED TO ADEQUATELY VENTILATE THE PATIENT. THE PATIENT EXPERIENCED DESATURATION AND DID NOT IMPROVE WHILE THE MEDLINE DEVICE WAS IN USE. UPON SWITCHING TO A PREVIOUSLY STOCKED RESUSCITATION BAG FROM ANOTHER BRAND, VENTILATION IMPROVED AND THE PATIENT'S OXYGEN SATURATION INCREASED. THE FACILITY REPORTED PROBLEMS WITH ADEQUATE DELIVERY OF POSITIVE PRESSURE WHEN THE BAG IS NOT HELD PERFECTLY STRAIGHT, AS PRESSURE IS LOST WHEN TORQUE IS APPLIED AT THE JUNCTION TO THE ADAPTER. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.