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

Model Number 6900LN-SEQ

Device Problems Power Problem (3010); Complete Loss of Power (4015)

Patient Problem No Information (3190)

Event Date 03/09/2020

Event Type  Injury  

Event Description

The patient is a tracheotomy patient using 3 lpm.The eclipse unit had a total power failure, and the patient had to be admitted to the hospital.

Event Description

The patient was traveling with family from (b)(6) to (b)(6).Five hours into their drive, the unit failed with a low oxygen purity alarm.The patient received a replacement unit (s/n (b)(6)) the next day from their distributor; however, this unit had a total power failure, and the patient had to be admitted to the hospital.The patient is a tracheotomy patient using 3 lpm.The patient received alternate oxygen, and made it back home using oxygen tanks.

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.The unit was returned for an evaluation.The root cause of the power failure experienced by the eclipse 5 was identified as a disconnected ribbon cable.The cable in question provides power to the main circuit board, therefore the unit could not function without it.Once the cable was reconnected to the board, the unit functioned normally, and it met its functional specifications.The unit arrived with 5 hours of total run time, and its traveler confirmed that it passed all final tests after assembly.This indicates that at some point after the unit left the factory, the ribbon cable came loose from the circuit board.The circumstances that led to the disconnection could not be determined.

• Brand Name: ECLIPSE 5
• Type of Device: CONCENTRATOR, OXYGEN, TRANSPORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 9936203
• MDR Text Key: 188201001
• Report Number: 3004972304-2020-00011
• 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,Followup
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 6900LN-SEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: 03/17/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 03/17/2020; 03/17/2020
• Supplement Dates FDA Received: 04/14/2020; 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization