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

Model Number 6900-SEQ

Device Problem Battery Problem (2885)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

We are attempting to get the unit returned for evaluation.If any new information is discovered, a followup report will be submitted.

Event Description

User had the unit on pulse setting 3 during a flight from (b)(6) to (b)(6).The first battery did not appear to last the listed battery time on their pulse setting, 4.9 hours.They switched to second battery during the flight and that only lasted 2 more hours then shut down, when they landed the user's o2 stats dropped to 50% and they had to seek medical help.User did not mention emergency landing to (b)(6).

Manufacturer Narrative

The unit was returned for evaluation, along with two batteries.The unit performed as intended when charging batteries.The unit charged both batteries while on ac power, switched to battery power when ac power was removed, and then charged the batteries again when ac power was reconnected.Of the two batteries received with the unit, the one marked as "bad battery" (battery 2) lasted less than 50% of the specified runtime outlined in the user manual.Battery 1 performed better than the specified runtime.This points to battery 2 malfunctioning.The unit produced oxygen levels within the 87-95.5% specification for all flow rates except 2.5 lpm and 3.0 lpm continuous.The unit also produced flow rates within the ±10% / 200 ml (whichever is greater) specification for each continuous flow rate.

• Brand Name: ECLIPSE
• Type of Device: CONCENTRATOR, OXYGEN, TRANSPORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 6851976
• MDR Text Key: 85609899
• Report Number: 3004972304-2017-00028
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6900-SEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1