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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. NEWLIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY

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CAIRE INC. NEWLIFE INTENSITY 10 CONCENTRATOR, OXYGEN, STATIONARY Back to Search Results
Model Number AS099-101
Device Problems Indicator; Adverse Event Without Identified Device or Use Problem; Insufficient Information
Event Date 04/04/2019
Event Type  Death  
Manufacturer Narrative

Unit is not being returned for evaluation. The end user has contacted a lawyer and is holding onto the unit. If any new information is discovered, a follow-up mdr will be submitted.

 
Event Description

This report was originally submitted on 5/10/2019, and is being resubmitted on 5/14/2020 as the original report failed to go through. Husband went to the store and left wife at home for 20 mins. Found wife deceased on floor with cannula next to wife. The newlife 10 was not in the room with wife, according to employee from (b)(6). Provider asked about getting the unit or dropping by to check 02. Husband says he contacted a lawyer and will hold on to the newlife for now. Also, husband thinks his wife was attempting to get back up oxygen due to the newlife having an orange light on.

 
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Brand NameNEWLIFE INTENSITY 10
Type of DeviceCONCENTRATOR, OXYGEN, STATIONARY
Manufacturer (Section D)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground, ga
Manufacturer (Section G)
CAIRE INC.
2200 airport industrial drive
suite 500
ball ground, ga
Manufacturer Contact
neal maloy
2200 airport industrial drive
suite 500
ball ground, ga  
7217700
MDR Report Key10057539
Report Number3004972304-2019-00028
Device Sequence Number1
Product CodeCAW
Report Source Manufacturer
Source Type DISTRIBUTOR
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2020
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberAS099-101
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 05/14/2020 Patient Sequence Number: 1
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