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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAIRE INC. SEQUAL EQUINOX

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CAIRE INC. SEQUAL EQUINOX Back to Search Results
Model Number 4807-SEQ
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Headache (1880); Burning Sensation (2146)
Event Type  No Answer Provided  
Manufacturer Narrative

The unit has been returned to the company for inspection and is currently pending non-destructive testing. Once the results have been received a followup report will be submitted.

 
Event Description

The company received notification of a series of alleged adverse events on april 14, 2016. The involved equinox was allegedly used by 4-5 people and they all experienced the same issue. The incidents were reported via email, stating "i did read the o2 levels and they are within 95-97% but after about 30 - 60 mins of use this machine emits something that makes people have headaches and a burning sensation in their throats. I have had 4-5 people try this and all have the same issue. I even had a metallic taste in my mouth. ".

 
Manufacturer Narrative

The unit was returned to the company for investigation. The unit was in good condition, per a visual inspection. The oxygen concentration was above 93% for all flow rates, which is within the 87 - 95. 5% acceptable range detailed in the device specifications. There were no indications of temperature induced issues such as melted foam, wires, connectors or plastic observed anywhere in the device. All wiring and connectors were found to be undamaged. The company was unable to reproduce the incident described. The cannula was not returned with the unit, so this could not be included in the evaluation of the device. The device was operating as designed and well within the acceptance criteria.

 
Event Description

The company received notification of a series of alleged adverse events on (b)(6) 2016. The involved equinox was allegedly used by 4-5 people and they all experienced the same issue. The incidents were reported via email, stating "i did read the o2 levels and they are within 95-97% but after about 30 - 60 mins of use this machine emits something that makes people have headaches and a burning sensation in their throats. I have had 4-5 people try this and all have the same issue. I even had a metallic taste in my mouth. ".

 
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Brand NameSEQUAL EQUINOX
Type of DeviceEQUINOX
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 Key5653832
MDR Text Key45153209
Report Number3004972304-2016-00017
Device Sequence Number1
Product Code CAW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK120785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/13/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number4807-SEQ
Device Catalogue Number4807-SEQ
Was Device Available For Evaluation? Yes
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? Yes
Date Device Manufactured04/12/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/13/2016 Patient Sequence Number: 1
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