MAUDE Adverse Event Report: INOVA LABS, INC LIFECHOICE ACTIVOX; PORTABLE OXYGEN CONCENTRATOR

Model Number XYC100B-PRO

Device Problem Failure to Power Up (1476)

Patient Problems Ventilator Dependent (2395); Loss of consciousness (2418)

Event Date 05/13/2015

Event Type  Death  

Event Description

A pt and his wife were traveling by airline for a 2 month stay in (b)(6) and provided a portable oxygen concentrator (poc) and 2 external batteries for the trip.On (b)(6) 2015 the pt and wife were sleeping during the first leg (estimated to be 7-9 hr) of flight from (b)(6), and when the wife awoke during the flight noting her husband, the pt, was turning "blue" in color (and apparently unconscious).The patient's wife observed the poc was not working and she thought the internal battery was depleted.The external battery was connected to the poc, but the poc did not restart.The patient's wife called the flight crew for assistance and oxygen from the aircraft was provided and the pt gained consciousness and was communicative.Upon landing in (b)(6), the pt was taken to the (b)(6) hosp where the pt is on artificial ventilation and possibly a medically induced coma.Information was provided to ansm on (b)(6) 2015 with the patient's wife saying her husband is unconscious and breathing on a ventilator.Both lungs are said to be irreparably damaged with a risk of heart attack and long term pt prognosis is life-threatening.The patient's pulmonologist was contacted on (b)(6)2015 as well as the airline.The poc and batteries were retained to present to the health and social affairs authority of (b)(6).At this time there are no further details as to pt identifying information, patient's medical history, patient's doctor information, air travel details (unanticipated flight factors such as delays), medical intervention details, or the patient's prescribed therapy.

Manufacturer Narrative

It appears that the pt was using incompatible lifechoice rechargeable external batteries with the activox portable oxygen concentrator.Review of the device history record for activox (b)(4) revealed no non-conformities.Since the device and external batteries used by the pt have not been returned, inova labs, inc.Performed interoperability testing using functional equivalents in efforts to simulate the event.Interoperability test results demonstrate that an activox portable oxygen concentrator can be operated using a lifechoice external battery, however, led indicators on the activox do not operate as described in the activox operator's manual.Inova labs has requested the return of activox dp13463 and lifechoice external battery (b)(4) for failure analysis to determine if there is damage to these specific items.More detailed information about patient's use expectations, product training, the event in question, relevant factors of patient's medical history and an update on the patient's current condition have been sought by scheduling a native language ((b)(6)) speaking person to contact the patient's family.As part of the investigation, a review of inova labs, inc.Complaint database was performed and found no similar events (interoperability problem leading to an injury) in the 3 years the activox portable oxygen concentrator has been marketed.As of (b)(6) 2015, 31,246 activox portable oxygen concentrators had been sold (19 in (b)(6)).On (b)(6) 2015, inova labs obtained information that the pt visited his oxygen provider on the day of departure and indicated he charged external batteries ((b)(4)) and activox portable oxygen concentrator (dp13463) in his home.During the visit the oxygen provider observed a no breath alarm, however, the pt continued to use activox dp13463 for 20 mins with no other alarms observed and the unit was delivering oxygen properly.The pt believed the battery life would be enough to cover the flight and planned to charge in (b)(6).It is unk precisely how long the device operated before the battery depleted.The patient's wife does not remember if an alarm sounded prior to the battery becoming depleted.Reference inova labs complaint # (b)(4).

Manufacturer Narrative

Inova labs has obtained information that the patient passed away at the end of (b)(6) 2015.The device and external batteries in question have not been returned to inova labs; however, pictures confirming the patient was using an activox portable oxygen concentrator with incompatible lifechoice external batteries have been obtained.It has been identified that the company inova labs sold the device and external batteries in question to and also the company that sold them directly to the patient were both unaware that lifechoice external batteries are not compatible with activox portable oxygen concentrators.Both companies have since been educated to the differences between the lifechoice and activox portable oxygen concentrators and their respective external batteries.

• Brand Name: LIFECHOICE ACTIVOX
• Type of Device: PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOVA LABS, INC; austin TX
• Manufacturer Contact: clifton fisher ; 3500 comsouth; suite 100; austin, TX 78744 ; 5126171740
• MDR Report Key: 4843722
• MDR Text Key: 5932677
• Report Number: 3008185181-2015-00001
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• PMA/PMN Number: K072688
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,foreign,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: XYC100B-PRO
• Device Catalogue Number: XYC100B-PRO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2014
• 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): Death; Hospitalization; Life Threatening