inforMED

LMT NOMAG IC 3.0

Received Mar 5, 2013 · Event occurred Mar 5, 2013

Report 2996450 · MDR key 2996450

Device

Generic name

Incubator, Neonatal Transport, Mri Compatible

Model number

LMT NOMAG IC 3.0

Catalog number

0100022-C

Lot number

*

Product problems

  • Fluid/Blood Leak

Patient

*

  • No Information

Narrative

Description of Event or Problem

IT WAS OBSERVED BY USERS THAT WATER FROM THE INCUBATOR'S HUMIDIFIER BOTTLE DRIPS THROUGH THE UNIT'S BOTTOM CHASSIS AND DIRECTLY ONTO ITS AC PLUG AND THE OUTLET OF THE UNIT'S POWER PACK. THE DRIPPING WATER IS UNAVOIDABLE AND HAPPENS WHEN INSTALLING OR ESPECIALLY REMOVING THE HUMIDIFIER BOTTLE IN ITS RECEPTACLE. THE INCUBATOR'S BOTTOM CHASSIS PLATE IS PERFORATED, AND BELOW IT IN THE TRANSPORT FRAME IS THE LARGE BOX HOLDING BATTERIES AND CIRCUITRY TO GENERATE 120 VOLTS AC DURING TRANSPORT. THE HUMIDIFIER BOTTLE IS ALMOST DIRECTLY ABOVE THE PLUG AND OUTLET OF THE BATTERY PACK. WATER FROM THE BOTTLE POURS THROUGH THE CHASSIS PLATE AND ONTO THE TOP OF THE BATTERY BOX WHERE SOME POURS OVER THE EDGE DIRECTLY INTO THE 120-VOLT AC OUTLET, OR WATER MAY DRIP DIRECTLY ONTO THE AC PLUG IF THE INCUBATOR IS SHIFTED SLIGHTLY FROM ITS INTENDED POSITION. (PROMINENT ARROW LABELS SHOW INTENDED POSITION, BUT IT IS EASY TO SHIFT A FEW INCHES FROM THAT.) SOME FORM OF CANOPY OR OTHER PROTECTION IS NEEDED TO KEEP THE DRIPPING WATER AWAY FROM THE 120-VOLT PLUG AND OUTLET ON THE BATTERY BOX.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PRODUCT IS USED TO MAINTAIN A WARM, HUMIDIFIED ENVIRONMENT FOR INFANTS DURING MR IMAGING.