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

Model Number 6900BT-SEQ

Device Problem Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The customer originally called in on (b)(6) 2019 to report an issue with the unit, but just said it wasn't working right.They said there were issues with the battery and it made a loud noise.A warranty replacement was shipped out and the unit was received on (b)(6) 2019 and treated like a normal repair replacement unit (case was not coded as an mdr and was not treated as an adverse event).The unit was processed on (b)(6) 2019 and ended up being scrapped.On (b)(6) 2019, caire received an email requesting reimbursement for expenses and the email indicated there was a spark and smoke.Because of this, an mdr case was initiated.The unit is not available for evaluation as it was received in on (b)(6) 2019 and scrapped out on (b)(6) 2019 prior to caire being notified of the unit being involved in a potential adverse event.

Event Description

Patient flying from (b)(6) for an eye specialists appointment.Battery ran out due to waiting for the plane.They did not have enough battery power to get through the flight.So had to get off the plane.They had to book a later flight after having time to charge the battery.Next day went to doctor's appointment.While there the poc beeped and orange light came on with no error.Battery showing to be more than half charged.Then after a few minutes light went back to green.Then after about an hour it happened again.Since she is a continuous oxygen patient when the unit stopped working she had to go to the emergency room.Er staff plugged in unit to check it and sparks and smoke blew out of the unit.They had to get her an oxygen company.This took time so she was unable to leave and had to stay in the hotel for 2 nights.

• 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
• 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 ; 7707217700
• MDR Report Key: 8917603
• MDR Text Key: 163299573
• Report Number: 3004972304-2019-00041
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6900BT-SEQ
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization