MAUDE Adverse Event Report: CAIRE INC. ECLIPSE; CONCENTRATOR, OXYGEN, TRANSPORTABLE

Model Number 6900-09-SEQ

Device Problem Failure to Deliver (2338)

Patient Problem No Code Available (3191)

Event Date 11/02/2017

Event Type  Death  

Manufacturer Narrative

Unit has not been returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

End user claimed the unit stopped providing oxygen on the plane.He found the unit could not be charged on the plane after boarding and he also took an additional battery however it held just 40 minutes then the unit shut down.Since his flight duration was 3.5 hours, he felt it hard to breathe even after the flight attendant gave him the emergency oxygen to support, the plane was urgently landed at another airport.The end user is still in the hospital and refused to provide the unit for evaluation.

Event Description

The (b)(4) fda did a battery duration test and we passed.The patient passed away but it was not caused by our product.The family will not return the unit back to us.

• Brand Name: ECLIPSE
• Type of Device: CONCENTRATOR, OXYGEN, TRANSPORTABLE
• 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 ; 7707217700
• MDR Report Key: 7084904
• MDR Text Key: 93806155
• Report Number: 3004972304-2017-00047
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K013931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6900-09-SEQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 65 YR