inforMED
InjuryDPZ

TRUSAT PULSE OXIMETER AND ACCESSORIES

Received Nov 16, 2010 · Event occurred Aug 4, 2010

Report 9613557-2010-00009 · MDR key 1907727

Device

Generic name

Pulse Oximeter

Manufacturer

Ge Healthcare

Model number

6051-0000-193

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.