inforMED
DeathLXJ

DIAGNOSTIC ACHIVES

Received Mar 17, 1995 · Event occurred Jan 18, 1993

Report 66762-1995-09001 · MDR key 22584

Device

Generic name

Optical Disk

Model number

202-124-1

Lot number

NA

Product problems

  • Display Difficult to Read

Patient

*

  • Death

Narrative

Description of Event or Problem

ACCORDING TO THE COMPLAINANT, SURGEON REPORTEDLY FAILED TO COMPLETE A QUADRUPLE AORTACORONARY BYPASS ON PT DUE TO AN ALLEGED BLANK SPOT ON A DISK RECORDED IN THE CATHETERIZATION LAB. THEHE ALLEGED BLANK SPOT WAS REPORTEDLY INTERPRETED AS THE CONCLUSION OF THE FILM SUPPOSEDLY LEADING TO AN ANOMALOUS CIRCUMFLEX ARTERY NOT BEING BYPASSED. IT IS THE ALLEGATION OF THE COMPLAINTANT THAT THIS RESULTED IN A MASSIVE MYOCARDIAL INFARCTION AND THE PT'S DEATH.THE INCIDENT WAS NOT PREVIOUSLY REPORTED AND IS BEING FORWARDED AT THISIME BY THE ATTORNEY FOR THE ADMINISTRIX OF THE ESTATE.