DeathDPZ
TRUSAT PULSE OXIMETER
Received Feb 17, 2011 · Event occurred Jan 13, 2011
Report 2124823-2011-00014 · MDR key 1999253
Device
Generic name
Oximeter
Manufacturer
Ge HealthcareProduct problems
- Insufficient Device Problem Information
Patient
28 YR
- Death
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PT WHO WAS USING A TRUSAT PULSE OXIMETER IN A HOME ENVIRONMENT DIED IN HER SLEEP. THE PT'S MOTHER REPORTED THAT SHE REC'D AN URGENT MEDICAL DEVICE CORRECTION LETTER FOR THE TRUSAT SEVERAL DAYS AFTER HER DAUGHTER'S DEATH. THE PT HAD BEEN DIAGNOSED WITH RETT SYNDROME. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.