FDA Adverse Event Injury Summary report: N

COMPANION 31

MDR report key: 1525985 · Received November 6, 2009

Report

Report Number: 1825511-2009-00006
Event Type: Injury
Date Received: November 6, 2009
Date of Event: August 31, 2009
Report Date: October 8, 2009
Manufacturer: PLAINFIELD-LOX-RX
Product Code: BYJ
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: ATTORNEY

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. AT THE TIME OF THE EVENT, THE PATIENT HAD FIVE LIQUID OXYGEN DEVICES IN THE HOME. IT IS NOT KNOWN WHICH UNIT OR UNITS WERE INVOLVED IN THE EVENT, THEREFORE, ALL FIVE ARE BEING REPORTED. REFERENCE MEDWATCH REPORTS: 1825511-2009-00005, 1825511-2009-00007, 1825511-2009-00008, AND 1825511-2009-00009. PRODUCT 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, "CLEAN AND DRY THE FILL CONNECTORS ON BOTH THE STATIONARY AND PORTABLE UNITS TO PREVENT FREEZING AND POSSIBLE EQUIPMENT FAILURE."

Description of Event or Problem · 1

IT WAS REPORTED: A PATIENT WAS FILLING A C1000 PORTABLE DEVICE FROM A C31 STATIONARY DEVICE. AT THE END OF THE FILL PROCESS, THE PATIENT WAS UNABLE TO SEPARATE THE TWO DEVICES. LIQUID OXYGEN THEN ESCAPED FROM THE CONNECTION, AND RAN DOWN THE SIDE OF THE STATIONARY UNIT TO THE CARPET. THE PATIENT SUSTAINED THERMAL INJURIES TO HIS LEFT FOOT REQUIRING MEDICAL INTERVENTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	COMPANION 31	STATIONARY LIQUID OXYGEN SYSTEM	BYJ	PLAINFIELD-LOX-RX	C31	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention\| S