MODEL 91369, SL2400 COMPACT MONITOR

Description of Event or Problem

INFANT PT WAS RESTING IN A BASSINET, UNDER AN INFANT WARMER WITH OXYGEN HOOD IN PLACE. OXYGEN HOOD WAS PLACED OVER THE INFANT'S HEAD AND WAS ATTACHED TO AN OXYGEN AIR BLADDER FOR ADMINISTRATION OF 100% OXYGEN. AS STAFF APPROACHED THE BASSINET, THEY OBSERVED A FLASH OF FLAMES UNDER THE OXYGEN HOOD. STAFF REMOVED HOOD AND REMOVED OXYGEN FROM THE WALL. STAFF USED A BLANKET TO EXTINGUISH FIRE.

Additional Manufacturer Narrative

THIS ISSUE IS THE SUBJECT OF A MEDWATCH THAT HAS BEEN REPORTED TO THE FDA BY THE HOSP. THIS REPORT IS INTENDED TO SERVE AS SPACELABS HEALTHCARE'S INITIAL MEDICAL DEVICE REPORT ON THIS MATTER. A FEW KEY FACTS SHOULD BE NOTED. DUE TO THE UNIQUENESS OF THE REPORTED EVENT, THE HOSP HAS CONTRACTED WITH OUTSIDE INVESTIGATORS TO PERFORM A COMPLETE INVESTIGATION INTO THE EVENT. HOSP HAS FILED THEIR MDR AND INCLUDED THE MANUFACTURERS OF ALL EQUIPMENT THAT WAS PRESENT IN THE PT'S ENVIRONMENT, BUT HAS NOT MADE ANY STATEMENT OF FAILURE OR MALFUNCTION ASSOCIATED WITH ANY PROD. THE INVESTIGATING TEAM IS CREATING AN INVESTIGATION PROTOCOL AT THIS TIME TO GOVERN THEIR INVESTIGATION, BUT HAS NOT [AT THIS TIME] STARTED AN INVESTIGATION. WE HAVE CONTACTED THE HOSP'S RISK MGMT VIA EMAIL AND LETTER DATED FEBRUARY 12, 2008 WITH AN ACKNOWLEDGEMENT LETTER REQUESTING PARTICIPATION IN THE EVAL OF SPACELABS HEALTHCARE EQUIPMENT. WE HAVE NO FIRM INDICATION [AT THIS TIME] WHEN WE WILL BE ABLE TO EVALUATE THE SPACELABS EQUIPMENT AS WE ARE NOT CONTROLLING THE INVESTIGATION. WE INTEND TO MAKE EVERY EFFORT TO ASSIST IN THE INVESTIGATION AS IT RELATES TO SPACELABS PRODS. WE HAVE REVIEWED OUR COMPLAINT FILES AND HAVE NOT REC'D ANY OTHER REPORTS OF EVENTS SIMILAR TO THIS REPORT.