FDA Adverse Event Other Summary report: N

HELIOS MARATHON H850

MDR report key: 774977 · Received October 20, 2006

Report

Report Number: 1825511-2006-00024
Event Type: Other
Date Received: October 20, 2006
Date of Event: August 5, 2006
Report Date: September 18, 2006
Manufacturer: PURITAN BENNETT (LOX), CRYOGENIC DIVISION
Product Code: BYJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. PRODUCT USER GUIDE WARNS: "DO NOT TOUCH LIQUID OR PARTS THAT HAVE BEEN IN CONTACT WITH LIQUID OXYGEN. LIQID 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. ALWAYS KEEP THE H850 PORTABLE IN ONE OF HTE FOLLOWING POSITIONS: UPRIGHT, FLAT ON ITS BACK OR ANY POSITION IN BETWEEN. USER GUIDE ALSO STATES, "IT IS IMPORTANT TO ALWAYS KEEP THE H850 PORTABLE IN ONE OF THESE POSITIONS OR LIQUID OXYGEN MAY ESCAPE."

Description of Event or Problem · 1

IT WAS REPORTED: A PATIENT, USING AN H850 PORTABLE LIQUID OXYGEN DEVICE, WAS OUT TO DINNER. THE PATIENT PLACED THE DEVICE ON THE BENCH NEXT TO HER. A COUPLE OF HOURS LATER, THE PATIENT FELT COLD ON HER LEG. THE PATIENT EXAMINED HER THIGH AND FOUND A BLISTER. THE PATIENT RECEIVED MEDICAL TREATMENT FOR THE INJURY 2 DAYS AFTER THE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	HELIOS MARATHON H850	PORTABLE LIQUID OXYGEN SYSTEM	BYJ	PURITAN BENNETT (LOX), CRYOGENIC DIVISION	H850	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	*		Required Intervention