MalfunctionBTM

AMBU SPUR II ADULT RESUSCITATOR

Received Apr 17, 2024 · Event occurred Dec 13, 2023

Report 19126164 · MDR key 19126164

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Manufacturer

Ambu A/s

Model number

520611000

Catalog number

520611000

Lot number

2000002763

Patient

46 YR · Male

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

AMBUBAG WAS NOT STRUCTURALLY CAPABLE OF FUNCTION. THE SELF-INFLATING PORTION OF THE BAG WAS NOT INFLATING. RESPIRATORY THERAPIST (RT) NOTICED BEFORE THE INTUBATION AND WAS ABLE TO LOCATE ANOTHER AMBUBAG THAT WAS FUNCTIONING.