MAUDE Adverse Event Report: INOVA LABS, INCORPORATED ACTIVOX P4L US STD PKG WITH EXT BATT

Model Number XYC100B-P4L

Device Problem Infusion or Flow Problem (2964)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

In response to this report resmed contacted the daughter to gather additional information.Resmed was informed the reason for her contacting the manufacturer was that she no longer wanted to work with her durable medical equipment (dme) provider and was requesting resmed to refund her $ for the last 3 months of the poc device lease.The daughter was informed that she would need to work with the dme in regards to the refund however, based on the nature of the event, resmed requested the return of the device for an engineering investigation.The daughter denied the request and the device as not returned for a formal investigation.A review of resmed service history records indicated the device was serviced by resmed for a reported poc oxygen concentrator output of low o2 (79%) in (b)(6) 2017, two months after the time of death.At the time the device was serviced and returned to sender there was no report of the device causing or contributing to a patient death.Resmed contacted the patients' dme in (b)(6) 2017 to obtain further information regarding the event.The dme was not aware of any allegation that the device contributed to the death.Based on the information provided to resmed at this time we are not able to determine or deny a connection between the reported death and the poc device.If the device is returned and the investigation completed or resmed obtains additional information then a follow up report with additional information will be provided.Per the activox operators manual, indication for use: the device is not life supporting nor life sustaining.Resmed reference (b)(4).(b)(4).Owner would not release for investigation.

Event Description

Resmed was made aware of a portable oxygen concentrator (poc) patient passing away.Per the reporter (patient's daughter), the (b)(6) male was using the poc while walking outside.The patient stated he was not getting enough oxygen, sat down and fainted.Emergency services were called and the patient was transported to the hospital.The patient later died at the hospital.

• Brand Name: ACTIVOX P4L US STD PKG WITH EXT BATT
• Manufacturer (Section D): INOVA LABS, INCORPORATED; 3500 comsouth drive, ste 100; austin TX 78744
• Manufacturer (Section G): RESMED CORP; 9001 spectrum center blvd; san diego CA 92123
• Manufacturer Contact: david duley ; 9001 spectrum center blvd; san diego, CA 92123
• MDR Report Key: 7043569
• MDR Text Key: 92468541
• Report Number: 3004604967-2017-01646
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: XYC100B-P4L
• Device Catalogue Number: XYC100B-P4L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/20/2017
• Device Age: 8 MO
• Event Location: Other
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86