DeathIZF
PLY C-OMCP-VISUB (H3000)
Received Aug 4, 2011 · Event occurred Jan 1, 2011
Report 3003768277-2011-00447 · MDR key 2196413
Device
Manufacturer
Philips HealthcareModel number
72238Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- Air Embolism
- Death
Narrative
Description of Event or Problem
PHILIPS WAS INFORMED THAT A PT DIED AFTER INJECTION OF AIR BY AN INJECTOR. INFORMATION WAS RECEIVED ON (B)(6), VIA AN EXTERNAL SOURCE, INDEPENDENT OF THE HOSPITAL AND UNRELATED TO PHILIPS WHICH LEADS PHILIPS TO THE CONCLUSION THAT AN ADVERSE EVENT INCIDENT HAS OCCURRED EARLIER AT A SITE WHERE OUR ENGINEER, APPARENTLY, SHORTLY AFTER THE INCIDENT OCCURRED WAS REQUESTED TO CHECK THE FUNCTIONALITY OF THE INJECTOR CONNECTED TO ONE OF OUR X-RAY SYSTEMS.
Additional Manufacturer Narrative
(B)(4). WHEN INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.