inforMED
MalfunctionILY

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Received Oct 4, 2011 · Event occurred Aug 23, 2011

Report 2299388 · MDR key 2299388

Device

Generic name

Heating, Lamp

Manufacturer

Natus Medical

Model number

42

Catalog number

*

Lot number

*

Product problems

  • Thermal Decomposition of Device
  • Device Emits Odor
  • Smoking

Patient

*

  • No Information

Narrative

Description of Event or Problem

A SMELL WAS NOTICED BY STAFF IN "BLUE" HALLWAY OF NICU. RN AND CNA TRIED TO LOCATE SOURCE AND COULD NOT. RN STATED IT SMELLED MOST IN ONE ROOM. WHEN RN WENT INTO ROOM SHE NOTICED A SMALL STREAM OF WHITE SMOKE COMING FROM THE TOP OF UNIT'S CONTROL BOX. THE UNIT WAS UNPLUGGED AND REMOVED FROM THE PATIENT'S ROOM. THE SMOKE HAD STOPPED AND THEY WATCHED THE UNIT FOR TEN MINUTES AT THE FRONT DESK WITH NO FURTHER SMOKE SEEN.BIOMED COMMENTS: SMOKE WAS DUE TO THE FUSE HOLDER BURNING UP. POSSIBLE ARCHING CAUSING FUSE HOLDER TO BURN AWAY. REPLACED FUSE HOLDER AND FUSE. PERFORMED SAFETY AND OPERATIONAL TEST.