inforMED
MalfunctionBTM

ALLEGIANCE/CARDINAL HEALTH

Received Sep 9, 2003 · Event occurred Aug 19, 2003

Report MW1029481 · MDR key 484070

Device

Generic name

Ambu Bags

Manufacturer

*

Model number

*

Catalog number

*

Lot number

Y1P0384

Product problems

  • Inflation Problem

Patient

47 YR

  • Unknown (for use when the patient's condition is not known)

Narrative

Description of Event or Problem

TWO SELF-INFLATING AIRLIFE AMBU BAGS REGULARLY STOCKED IN THE E.R. AND PURCHASED THROUGH ALLEGIANCE BY HOSP WERE INDENTIFIED AS HAVING FAILED TO REINFLATE WHILE IN USE DURING A RESUSCITATION IN THE ER IN 2003.