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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. AIRSEP NEWLIFE FAMILY NEWLIFE ELITE, INTENSITY AND INTENSITY 10

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CAIRE INC. AIRSEP NEWLIFE FAMILY NEWLIFE ELITE, INTENSITY AND INTENSITY 10 Back to Search Results
Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Patient Involvement (2645)
Event Type  No Answer Provided  
Manufacturer Narrative

This is not an adverse event, but since the user facility submitted a medwatch report, the company chose to submit one as well. The newlife elite, intensity and intensity 10 are part of the newlife family. The device model name is clearly identified on the front of the unit in large bold letters. The flow meters are clearly marked with the flow range limits. In addition, the accompanying user manual clearly indicates the device model and specifications.

 
Event Description

The company was notified on april 14, 2016 of a medwatch report that was submitted by a user facility. The submitted medwatch report stated: "airsep corporation manufactures three oxygen concentrators. The newlife elite and two versions of the newlife intensity. The newlife elite is a 5l concentrator while the two versions of the newlife intensity are 8l and 10l. Each of the three units look very similar to one another and none of them clearly say what volume of oxygen the machine is capable of concentrating. This resulted in a problem when a patient was supposed to receive an 8l concentrator, but received the 5l concentrator in error. The 5l concentrator was delivered as a result of the similarity in appearance of the two concentrators. A suggested course of action would be for the manufacturer to change the outer appearance of the concentrators to make it easier to differentiate between them and to clearly label the volume each is capable of concentrating. " there were no injuries or malfunctions with a device. Please see the additional manufacturer narrative for more information.

 
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Brand NameAIRSEP NEWLIFE FAMILY
Type of DeviceNEWLIFE ELITE, INTENSITY AND INTENSITY 10
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
Manufacturer (Section G)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground GA 30107
Manufacturer Contact
neal maloy
2200 airport industrial drive
suite 500
ball ground, GA 30107
7707217712
MDR Report Key5658069
MDR Text Key45277253
Report Number3004972304-2016-00021
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK960309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 05/16/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/16/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator DEVICE UNATTENDED
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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