FDA Adverse Event Death Summary report: N

COMPANION 1000

MDR report key: 1102983 · Received August 8, 2008

Report

Report Number: 1825511-2008-00009
Event Type: Death
Date Received: August 8, 2008
Date of Event: July 19, 2008
Report Date: August 4, 2008
Manufacturer: PLAINFIELD-LOX-RX
Product Code: BYJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME. ONCE THE DEVICE IS RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED WITH OUR INVESTIGATION RESULTS. PRODUCT LABELING WARNS: "WARNING DANGER OF FROSTBITE. KEEP EQUIPMENT UPRIGHT AT ALL TIMES." USER MANUAL WARNS: "DO NOT TOUCH LIQUID OXYGEN OR PARTS THAT HAVE BEEN IN CONTACT WITH LIQUID OXYGEN. LIQUID OXYGEN IS EXTREMELY COLD (-297 DEGREES FAHRENHEIT/-183 DEGREES CELSIUS). WHEN TOUCHED, LIQUID OXYGEN, OR PARTS OF THE EQUIPMENT THAT HAVE BEEN CARRYING LIQUID OXYGEN, CAN FREEZE SKIN AND BODY TISSUE." ADDITIONALLY, "KEEP AND USE THIS EQUIPMENT IN AN UPRIGHT POSITION AT ALL TIMES. IF THE STATIONARY OR PORTABLE UNIT IS TURNED OVER, GASEOUS OR LIQUID OXYGEN WILL ESCAPE."

Description of Event or Problem · 1

IT WAS REPORTED: A PT WAS USING A C1000 PORTABLE LIQUID OXYGEN DEVICE AT 6 LITERS PER MINUTE WITH AN OXIMIZER CANNULA. THE PORTABLE DEVICE WAS KNOCKED OVER AND LIQUID OXYGEN TRAVELED THROUGH THE CANNULA TUBING TO THE PT. THE PT SUFFERED BURNS TO HER NOSE FROM THE LIQUID OXYGEN. THE PT REQUIRED HOSPITALIZATION AND SURGERY FOR THE INJURY. THE PT EXPIRED IN THE HOSPITAL IN 2008.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COMPANION 1000	LIQUID OXYGEN (LOX) SYSTEM	BYJ	PLAINFIELD-LOX-RX	C1000	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	95 YR		Death\| H