MAUDE Adverse Event Report: CAIRE INC. FREESTYLE; OXYGEN CONCENTRATOR, PORTABLE

Model Number AS095-101

Device Problem Circuit Failure (1089)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Unit has not been returned for evaluation.If any new information is discovered, a follow-up report will be submitted.

Event Description

Several components failed on circuit board- smoke smell.Device has not been used by customer.

Manufacturer Narrative

Unit was returned for evaluation.Through investigation of the unit, it can be concluded that the incident started from the c24 capacitor on the circuit board.The c22 capacitor was shorted which could have caused too much power to the c24 capacitor which the incident could have started from.The damage from the incident included damage to surrounding components on the board and slight burn on the inside of the front case.No further testing is recommended.

• Brand Name: FREESTYLE
• Type of Device: OXYGEN CONCENTRATOR, PORTABLE
• Manufacturer (Section D): CAIRE INC.; 2200 airport industrial drive; suite 500; ball ground GA 30107
• MDR Report Key: 7001336
• MDR Text Key: 91297220
• Report Number: 3004972304-2017-00036
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K020324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AS095-101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1