inforMED
MalfunctionFPL

AIR-VAC TRANSPORT INCUBATOR

Received Jan 5, 1994

Report MW1000299 · MDR key 10790

Device

Manufacturer

Ohmeda

Product problems

  • Design/structure problem
  • Material Separation

Patient

*

Narrative

Description of Event or Problem

INSIDE THE INCUBATOR'S PLEXIGLASS HOOD, THERE IS A THERMOMETER IN A THERMOMETER HOLDER WHICH IS GLUED TO THE HOOD. THE HOLDER BECOMES UNGLUDED AND FALLS INTO THE INCUBATOR. RECENTLY, THERE WERE 2 INCIDENTS WHERE THE THERMOMETER BARELY MISSED INFANTS. THE REPORTER NOTIFIED THE MFR OF THE PROBELM AS FAR BACK AS 3 YRS AGO. SINCE 1987, THERE HAVE BEEN 21 INCIDENTS; 4 REPORTS WERE MADE TO THE MFR. THIS INFO WAS SUBMITTED AS F/U 3/10/94: ANOTHER INCIDENT OCCURED ON 3/4/94.