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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SALTER LABS SALTER LABS CONNECTOR
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SALTER LABS SALTER LABS CONNECTOR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Burn(s) (1757)
Event Date 06/02/2012
Event Type  Death  
Event Description
On 11/20/2014 salter labs was informed of an event that occurred on (b)(6) 2012.This is the first time that salter labs has received this information.Nature of the event: a pt's family reported that a pt was using oxygen equipment when suddenly, and without warning, the equipment caught fire and exploded causing significant injuries including burns to the pt's face and body.The pt died a day after of this incident.The oxygen equipment included: oxygen concentrator (non-salter labs branded), two cannulas (non-salter labs branded), a 25' oxygen tubing connector (non-salter labs branded), and a connector salter labs branded.Salter labs has not received the connector for analysis.Salter labs has not had any complaints regarding this issue.
 
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Brand Name
SALTER LABS CONNECTOR
Type of Device
CONNECTOR
Manufacturer (Section D)
SALTER LABS
2365 camino vida roble
carlsbad CA 92011
Manufacturer Contact
aurelia brownridge
2365 camino vida roble
carlsbad, CA 92011
7604974354
MDR Report Key4289106
MDR Text Key5197348
Report Number3000219639-2014-00011
Device Sequence Number1
Product Code CAT
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
AND TWO CANNULAS.; INCLUDED AN OXYGEN CONCENTRATOR, 25' TUBING,; THE CONNECTOR WAS PART OF AN OXYGEN CIRCUIT THAT
Patient Outcome(s) Death;
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