inforMED
MalfunctionLHC

*

Received Sep 30, 2009 · Event occurred Sep 29, 2009

Report 1501441 · MDR key 1501441

Device

Generic name

Warming Cabinet

Manufacturer

Getinge Castle

Model number

5624

Catalog number

*

Lot number

*

Product problems

  • Thermal Decomposition of Device

Patient

*

  • No Patient Involvement

Narrative

Description of Event or Problem

LAUNDRY WORKER FOUND A BLANKET WITH MULTIPLE BURN MARKS ON IT. THE BLANKET HAD COME FROM MED-SURG. EXAMINATION REVEALED 8 SEPARATE MARKS THAT LINED UP WHEN BLANKET WAS FOLDED. CONSULTATION WITH NURSING STAFF ON THAT UNIT DID NOT RESULT IN A PLAUSIBLE EXPLANATION OF OBSERVATIONS. SMOKING BY PATIENT WAS RULED OUT. WE CALLED IN A FIRE INVESTIGATOR/LICENSED PROFESSIONAL ENGINEER WHO DID A SYSTEMS REVIEW. THE ONLY EXPLANATION THAT WAS CONSISTENT WITH OBSERVED DATA WAS THE FOLLOWING:BLANKET HAD BEEN PLACED IN BLANKET WARMER IN SUCH A WAY AS TO BLOCK THE WARM AIR VENT. CABINET TEMPERATURE WAS SET AT 140 DEGREES F. HEAT BUILD-UP INSIDE THE CABINET AT THE VENT SITE PROBABLY WAS SUFFICIENT TO INITIATE PYROLYSIS OF THE FABRIC.DUE TO THE POTENTIAL FOR FIRE, WITH OBVIOUS IMPLICATIONS FOR PATIENT, HEALTH CARE WORKER AND VISITOR SAFETY, WE BELIEVE THIS REPORT SHOULD BE REVIEWED CAREFULLY.THE MANUFACTURER FOUND THAT CALIBRATION OF THE BLANKET WARMER'S CONTROL SYSTEM WAS WITHIN SPECIFICATION. HOWEVER, THE TEMPERATURE SETTING OF 140F WAS WELL ABOVE THE MANUFACTURER'S RECOMMENDED SET TEMP. OF 120F. THE OPERATOR'S MANUAL ALSO STATES THAT AIR VENTS MUST NOT BE BLOCKED. WE HAVE SEVERAL OF THESE WARMING CABINETS AT OUR FACILITY AND HAVE CHECKED THEM ALL TO ENSURE THAT THEY ARE NOT SET ABOVE THE RECOMMENDED 120F. WE HAVE ALSO DEVELOPED AND DISTRIBUTED A POLICY COVERING BLANKET AND SOLUTION WARMERS. WE ARE WORKING OUT PROTOCOL FOR BIOMED OR ELECTRICIAN TO MONITOR TEMPERATURE SETTINGS. WE ALSO THINK THAT THE MANUFACTURER COULD DEVELOP A SIMPLE GUARD THAT WOULD PROVIDE AN ENGINEERING CONTROL SO THAT SOMEONE COULD NOT BLOCK THE VENT WITH A BLANKET.

Description of Event or Problem

LAUNDRY WORKER FOUND A BLANKET WITH MULTIPLE BURN MARKS ON IT. THE BLANKET HAD COME FROM MED-SURG. EXAMINATION REVEALED 8 SEPARATE MARKS THAT LINED UP WHEN BLANKET WAS FOLDED. CONSULTATION WITH NURSING STAFF ON THAT UNIT DID NOT RESULT IN A PLAUSIBLE EXPLANATION OF OBSERVATIONS. SMOKING BY PATIENT WAS RULED OUT. WE CALLED IN A FIRE INVESTIGATOR/LICENSED PROFESSIONAL ENGINEER WHO DID A SYSTEMS REVIEW. THE ONLY EXPLANATION THAT WAS CONSISTENT WITH OBSERVED DATA WAS THE FOLLOWING:BLANKET HAD BEEN PLACED IN BLANKET WARMER IN SUCH A WAY AS TO BLOCK THE WARM AIR VENT. CABINET TEMPERATURE WAS SET AT 140 DEGREES F. HEAT BUILD-UP INSIDE THE CABINET AT THE VENT SITE PROBABLY WAS SUFFICIENT TO INITIATE PYROLYSIS OF THE FABRIC.DUE TO THE POTENTIAL FOR FIRE, WITH OBVIOUS IMPLICATIONS FOR PATIENT, HEALTH CARE WORKER AND VISITOR SAFETY, WE BELIEVE THIS REPORT SHOULD BE REVIEWED CAREFULLY.THE MANUFACTURER FOUND THAT CALIBRATION OF THE BLANKET WARMER'S CONTROL SYSTEM WAS WITHIN SPECIFICATION. HOWEVER, THE TEMPERATURE SETTING OF 140F WAS WELL ABOVE THE MANUFACTURER'S RECOMMENDED SET TEMP. OF 120F. THE OPERATOR'S MANUAL ALSO STATES THAT AIR VENTS MUST NOT BE BLOCKED. WE HAVE SEVERAL OF THESE WARMING CABINETS AT OUR FACILITY AND HAVE CHECKED THEM ALL TO ENSURE THAT THEY ARE NOT SET ABOVE THE RECOMMENDED 120F. WE HAVE ALSO DEVELOPED AND DISTRIBUTED A POLICY COVERING BLANKET AND SOLUTION WARMERS. WE ARE WORKING OUT PROTOCOL FOR BIOMED OR ELECTRICIAN TO MONITOR TEMPERATURE SETTINGS. WE ALSO THINK THAT THE MANUFACTURER COULD DEVELOP A SIMPLE GUARD THAT WOULD PROVIDE AN ENGINEERING CONTROL SO THAT SOMEONE COULD NOT BLOCK THE VENT WITH A BLANKET.