FDA Adverse Event Death Summary report: N

GENERAL ELECTRIC MEDICAL SYSTEMS

MDR report key: 340457 · Received July 2, 2001

Report

Report Number
MW1022322
Event Type
Death
Date Received
July 2, 2001
Date of Event
June 12, 2001
Report Date
July 2, 2001
Manufacturer
GENERAL ELECTRIC MEDICAL SYSTEMS
Product Code
FQO
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PT JUST COMPLETED PTCA PROCEDURE, REQUESTED BED PAN AND ROLLED OFF TABLE DURING PLACEMENT OF BED PAN. FALL RESULTED IN RUPTURED SPLEEN, BROKEN RIBS AND SUBDURAL HEMATOMA, PT DIED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
29919 GENERAL ELECTRIC MEDICAL SYSTEMS OMEGA IV ANGIO STEP OPERATING TABLE FQO GENERAL ELECTRIC MEDICAL SYSTEMS ANGIO STEP *

Patients

Seq Age Sex Outcome Treatment
1 81 YR Death