FDA Adverse Event Injury Summary report: N

218STROLLER - PORTABLE OXYEGON CONTAINER

MDR report key: 939450 · Received November 5, 2007

Report

Report Number: MW5004347
Event Type: Injury
Date Received: November 5, 2007
Date of Event: November 1, 2007
Report Date: November 2, 2007
Manufacturer: CAIRE , INC.
Product Code: BYJ
Adverse Event: Yes
Product Problem: Yes
Report Source: Voluntary report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Description of Event or Problem · 1

IN 2007, PATIENT WAS USING PORTABLE LIQUID OXYGEN CONTAINER DEVICE. SUSTAINED INJURIES (BURNS TO FACE, NECK AND NOSE) AS A RESULT OF DEVICE MALFUNCTIONING. FROZEN ICE PARTICLES WENT FROM DEVICE THROUGH PLASTIC TUBING (OXYGEN CLEAR PLASTIC TUBE). TUBING "FROZE/ICED" INTO PTS FACE AND NECK. PATIENT RECEIVED MEDICAL TREATMENT. INFORMED OXYGEN PROVIDER - AMERICA'S BEST/LINCARE.

Description of Event or Problem · 1

THIS IS ADDENDUM TO REPORT SUBMITTED 11/02/2007 BY REPORTER. REPORT MADE ON BRAND NAME DEVICE STROLLER- PORTABLE MODEL- LIQUID OXYGEN CONTAINER, LISTED MFR AS CAIRE INC. THIS ADDENDUM DETAILS ADDITIONAL INFO. REPORTER IS ADMINISTRATOR OF NURSING HOME- FOR SENIOR LIVING. MANUFACTURER LISTED AS CAIRE INC- NOTE-- PART OF CHART INDUSTRIES RELATED NOTES? CAIRE MEDICAL- WEB SITE HAS ALERT BULLETIN, 04/22/2004 DETAILING PRODUCT ISSUES- ICE BUILD UP FOR STROLLER PORTABLE MODELS. ALSO, VERY IMPORTANT TO NOTE FDA ADVERSE EVENT REPORT THE FOLLOWING MONTH, TITLED CHART INDUSTRIES INC STROLLER TOPFILL PORTABLE LIQUID OXYGEN DEVICE!!! APPEARS THAT INJURIES NOTED ON THIS FDA NOTICE OF THE SAME DAY, ARE SIMILAR TO INJURIES NOTED BY THIS REPORTER. ALSO SAME TYPE OF DEVICE- STROLLER-- BY CHART INDUSTRIES!!

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	218STROLLER - PORTABLE OXYEGON CONTAINER	STROLLER	BYJ	CAIRE , INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR		Hospitalization\| O