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

Model Number 4837-SEQ

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2018

Event Type  malfunction  

Manufacturer Narrative

Unit is being returned for evaluation.If any new information is discovered, a follow up report will be submitted.

Event Description

This report was originally submitted on 9/4/2018, and is being resubmitted on 4/24/2020 as the original submission failed to go through.Vitality medical has been in contact with the customer's daughter.Our customer just recently got it back from this last repair and says that there is a yellow steady light that won't come off, the battery is flashing, the diagnostic comes up with an alarm 0100 and then a red light and code fail 94 comes on and the unit shuts down.On this last one her mother was using the unit when it shut off and she had to rush to get an oxygen tank as she is life dependent on the machine.

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." unit is not available for testing.Based on the description of the incident, the unit was alarming as intended.Also, the unit is not intended for life sustaining purposes.

Event Description

This report was originally submitted on 8/8/2019, and is being resubmitted on 7/6/2020 as the original submission failed to go through.Vitality medical has been in contact with the customer's daughter.Our customer just recently got it back from this last repair and says that there is a yellow steady light that won't come off, the battery is flashing, the diagnostic comes up with an alarm 0100 and then a red light and code fail 94 comes on and the unit shuts down.On this last one her mother was using the unit when it shut off and she had to rush to get an oxygen tank as she is life dependent on the machine.

• Brand Name: EQUINOX
• Type of Device: CONCENTRATOR, OXYGEN, TRANSPORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground, ga
• MDR Report Key: 9998499
• MDR Text Key: 190361567
• Report Number: 3004972304-2018-00036
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K120785
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 4837-SEQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Initial Date Manufacturer Received: 08/06/2018
• Initial Date FDA Received: 04/24/2020
• Supplement Dates Manufacturer Received: 08/06/2018
• Supplement Dates FDA Received: 07/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1