inforMED
MalfunctionLHC

AMSCO WARMING CABINET - 5TH GENERATION

Received Dec 3, 2007 · Event occurred Sep 29, 2007

Report 1043572-2007-00025 · MDR key 960221

Device

Generic name

Warmer, Irrigation, Solution

Model number

2721443

Catalog number

2721443

Lot number

NA

Product problems

  • Component(s), overheating of

Patient

YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

WHEN THE STERIS TECHNICIAN ARRIVED, HE OBSERVED THAT THE CONTROL SECTION HAD BEEN REMOVED FROM THE UNIT. IT WAS IN THE CLINICAL ENGINEERING WORKSHOP, ON A TABLE. ON THE CONTROL SECTION ITSELF HE OBSERVED A PLUG AND WIRES THAT HAD MELTED. HE ALSO OBSERVED THE TEMPERATURE SETTINGS WERE AT 150 DEGREES FOR THE UPPER SECTION AND 155 DEGREES FOR THE LOWER SECTION. UNIT IS MAINTAINED BY THE FACILITY CLINICAL ENGINEERING DEPARTMENT. THE FIRE WAS CONTAINED AND WAS VERY SMALL (APPROXIMATELY THE SIZE OF A WALNUT), INVOLVING THE WIRE AND A PLUG ON THE CONTROL SECTION. THE UNIT WAS TAKEN OUTSIDE BEFORE THE FLAME DEVELOPED. NO ONE WAS INJURED.

Additional Manufacturer Narrative

STERIS HAS REQUESTED THE RETURN OF THE WARMING CABINET CONTROL FOR ENGINEERING EVALUATION TO DETERMINE ROOT CAUSE. FACILITY HAS DISPOSED OF CABINET, BUT IS RETURNING THE CONTROL. CONTROL RECEIVED ON 11/07/2007. THE FIRE WAS CONTAINED AND WAS VERY SMALL (APPROXIMATELY THE SIZE OF A WALNUT), INVOLVING THE WIRE AND A PLUG ON THE CONTROL SECTION. THE UNIT WAS TAKEN OUTSIDE BEFORE THE FLAME DEVELOPED. NO INJURIES REPORTED. PHOTOS OF THE DAMAGE WERE REVIEWED. PHOTOS INDICATE THE MERCURY RELAY SWITCH WAS NOT MOUNTED ON THE BRACKET. THE CONNECTORS APPEAR TO HAVE SUSTAINED ARCING OR SOME TYPE OF DAMAGE FROM OVERHEATING. IT IS POSSIBLE THAT THE PINS MAY HAVE BACKED OUT OF THE CONNECTOR TO CREATE A LOOSE CONNECTION WHICH COULD BE THE CAUSE OF FIRE. UNIT IS MAINTAINED BY THE FACILITY BIOMEDICAL DEPARTMENT, NOT STERIS.