inforMED
InjuryFPL

AVIATOR

Received Mar 19, 2010 · Event occurred Mar 7, 2010

Report MW5015223 · MDR key 1638181

Device

Generic name

Transport Incubator

Model number

AVIATOR

Product problems

  • Use of Device Problem
  • Misassembly by Users

Patient

0 DA

  • Death
  • Respiratory Failure

Narrative

Description of Event or Problem

INFANT WAS PLACED IN TRANSPORT ISOLETTE IN PREPARATION FOR HELICOPTER TRANSPORT. AFTER BEING PLACED IN TRANSPORT ISOLETTE, PT'S CONDITION STARTED TO DECLINE. HE WAS PLACED BACK IN ORIGINAL ISOLETTE AND STARTED TO IMPROVE. UNIT WAS CHECKED BY MANUFACTURE'S REP AND IT WAS FOUND THAT AIR AND O2 LINES WERE SWITCHED GOING TO MIXER. INSTRUCTIONS FOR CHECKING UNIT INDICATED THAT IT SHOULD BE CHECKED AT 60%, BUT THIS WOULD NOT DETECT SWITCHED LINES.