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

Model Number EQUINOX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/03/2016

Event Type  Injury  

Manufacturer Narrative

The unit was returned for repair before the patient's wife said it made her husband sick.The unit was already repaired before the company was informed of an adverse event.Several components that were replaced under normal repair were recovered and are undergoing testing.Once this testing is completed, a follow-up report will be submitted.

Event Description

The company was informed on (b)(6) 2016 of an adverse event that involved an equinox oxygen concentrator.The unit seemed to have a burning smell but did not exhibit any alarms.The patient's wife believes that her husband ended up sick and in the hospital because of this unit.

Event Description

The unit was returned and tested.Visual, pcba and final tests were performed with an overall result of pass.These boards meet the performance requirements individually and in a system.

• Brand Name: EQUINOX
• Type of Device: OXYGEN CONCENTRATOR, 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 ; 7707217712
• MDR Report Key: 6141712
• MDR Text Key: 61342652
• Report Number: 3004972304-2016-00040
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2017

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: EQUINOX
• Device Catalogue Number: 4807-SEQ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 12/02/2016
• Supplement Dates Manufacturer Received: 11/03/2016
• Supplement Dates FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization