InjuryDPZ
TRUSAT PULSE OXIMETER AND ACCESSORIES
Received Nov 16, 2010 · Event occurred Aug 4, 2010
Report 9613557-2010-00009 · MDR key 1907727
Device
Product problems
- Malposition of Device
Patient
12 YR
- Respiratory Distress
- Strangulation
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A (B)(6) CHILD WAS BEING MONITORED ON A TRUSAT PULSE OXIMETER USING AN OXYTIP FINGER SENSOR. THE PT'S MOTHER REPORTEDLY HEARD THE CHILD "GASPING" AND FOUND THE CABLE FROM THE PROBE WRAPPED AROUND THE CHILD'S NECK. THE MOTHER REMOVED THE PROBE AND THE PT SUFFERED NO LASTING HARM. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.