MAUDE Adverse Event Report: CAIRE INC. ECLIPSE 5; OXYGEN CONCENTRATOR, TRANSPORTABLE

Model Number 6900-08-SEQ

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Fainting (1847)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

Before caire was made aware of this incident, the end user returned the unit to the distributor for inspection, who in turn sent it to caire (b)(4) where it was assessed.A service order report dated may 28, 2020 states: "unit inspected.Initial purity readings good/stable.Battery recalibrated, unit tested and charging off both ac and dc power sources.Unit was tested for 48hrs and met performance specifications.No fault found." caire returned the device to the distributor.After caire became aware of the incident, the return of the unit was requested from the distributor.The device was returned to caire for further investigation.If any new information is discovered, a follow-up report will be submitted.

Event Description

The reporter of the incident was the patient's father.The father bought an eclipse 5 unit from the distributor for his young son who is already supplied with lox oxygen delivery systems.He bought the e5 to give his son a supply of oxygen when out of the house.On (b)(6) 2020, the customer plugged the device into the dc charger of his car so that his son would have a supply of oxygen during a car journey.After a short period of driving, his son showed symptoms such as drowsiness and reduced response to his father, but did not faint, he was worried enough to call paramedics to the scene who treated him with oxygen.There were no lasting ill effects.The incident took place in (b)(6).The father was taking his son to a special clinic in (b)(6) for people with lung problems.The father stated that the machine failed to work, and he had switched the oxygen supply from lox portable to the eclipse 5.Attempts to change the settings appeared to have no effect.The child deteriorated and stopped responding.The father switched back to the lox portable backup, stopped the car and called an ambulance.They had to go to a hospital.Before caire was made aware of this incident, the end user returned the unit to the distributor for inspection, who in turn sent it to caire (b)(4) where it was assessed.A service order report dated may 28, 2020 states: "unit inspected.Initial purity readings good/stable.Battery recalibrated, unit tested and charging off both ac and dc power sources.Unit was tested for 48hrs and met performance specifications.No fault found." caire returned the device to the distributor.

Manufacturer Narrative

Pursuant to title 21 - food and drugs, chapter i - food and drug administration department of health and human services, subchapter h -0 medical device, part 803 - medical device reporting, subpart a - general provisions, section 803.16, neither this report nor any information submitted herein constitutes an admission by caire inc.That the device stated in this report, caire inc., or caire inc.'s employees, caused or contributed to the reportable event stated herein.Before caire was made aware of this incident, the end user returned the unit to the distributor for inspection, who in turn sent it to caire wokingham where it was assessed.A service order report dated may 28, 2020 states: "unit inspected.Initial purity readings good/stable.Battery recalibrated, unit tested and charging off both ac and dc power sources.Unit was tested for 48hrs and met performance specifications.No fault found." caire returned the device to the distributor.After caire became aware of the incident, the return of the unit was requested from the distributor.The device was returned to caire for further investigation.Further investigation determined there were no issues identified with the eclipse device.The device functioned correctly and met all required specifications.

• Brand Name: ECLIPSE 5
• Type of Device: OXYGEN CONCENTRATOR, TRANSPORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground, ga
• MDR Report Key: 10197377
• MDR Text Key: 201201383
• Report Number: 3004972304-2020-00022
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K013931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6900-08-SEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 2 YR