MAUDE Adverse Event Report: OPTUMHEALTH CARE SOLUTIONS, INC. OPTUM TELEHEALTH; OPTUM TELEHEALTH APPLICATION

Device Problem Charging Problem (2892)

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

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

Optum telehealth (oth) application is client/server software application designed to retrospectively monitor vital signs and physiological data for review and analysis by clinicians.The software consists of web based application for clinician use, the client application for member use and web services.The application allows for data input from external biometric measuring devices, review of clinical advice and response of clinician questions and viewing of graphed data.The client application is available in two configurations, a stand-alone application and the application pre-loaded on (b)(6) tablets.Optumhealth care solutions (ohcs) pre-loads the oth software onto 3 different android tablets including (b)(6) tablets.The event occurred not with the oth software, or with the platform, but with the samsung ac power adapter to the tablet (not made by ohcs).When ohcs operational center received the tablet, usb cord and damaged ac adapter, ohcs tested the oth software on february 23, 2017 and the software was still functional.Ohcs operational center was unable to complete analysis of ac adapter malfunction.Therefore, ohcs notified the manufacturer of the tablet and adapter, (b)(6), of this issue and the damaged ac adapter was shipped to and received by (b)(6) on march 13, 2017.Ohcs still awaiting (b)(6) notification of findings.The reporter completed on preliminary examination of the damaged the ac adapter.Event problem codes may need to be updated based on (b)(6) analysis findings of malfunctioning ac adapter.As of 3.21.17, ohcs still awaiting (b)(6) findings.Reporting outside of 30 days: on february 23, 2017, the preliminary conclusion was this event was not reportable as the oth software was fully operational and the event was isolated an accessory, the samsung ac adapter.However, upon further analysis and due to an abundance of caution, oth has concluded to move forward reporting this event.

Event Description

En (patient) advised that he received the (b)(6) tablet pre-loaded with optum telehealth (oth) application, a samsung ac adapter and usb cord on (b)(6) 2014 as part of an optumhealth care solution (ohcs) disease management program.En was shipped a replacement usb cord on (b)(6) 2016 due to normal wear; the original samsung ac adapter was still in use.En stated that he used the oth software on the (b)(6) tablet on (b)(6) 2017 prior to leaving on vacation.En advised that in the evening, on (b)(6) 2017, he smelled burning plastic in his bedroom, but was too tired to figure out the cause of the smell.En elaborated that when he awoke the next morning the smell of burning plastic was even stronger, so he looked around and noticed the black soot/charring marks on the wall near the outlet where the (b)(6) tablet was plugged in.En asserted that no other items were plugged into the electrical outlet.En said that the black smoke had also stained his ceiling.En said he removed the plug from the wall outlet and noticed that the power cord to the tablet had melted about an inch above the three prongs that go into the wall outlet.En added that when he pulled the plug from the wall the cord actually broke in two pieces where it had melted.En notified oth helpline of the issue on january 30, 2017.A box and return label along with a replacement ac adapter and usb cord were sent to en on january 31, 2017.The damaged ac adapter, usb cord and the (b)(6) tablet were received by ohcs operational center on february 8, 2017.En was sent a replacement tablet on february 15, 2017.The oth software and the (b)(6) tablet were evaluated on february 23, 2017 and both were found fully operational.The damaged ac adapter was unable to be fully evaluated by ohcs because ohcs is not the manufacturer of the ac adapter and the analysis is outside of ohcs capabilities.Ohcs operational director contacted (b)(6), the manufacturer of the ac adapter, on march 6, 2017 to report ac adapter issue.(b)(6) requested ohcs to send damaged ac adapter to analyze.Ohcs operations sent out the ac adapter on march 6, 2017 and it was received by (b)(6) on march 13, 2017.As of march 22, 2017, ohcs is still waiting for notification from (b)(6) of cause analysis of damaged ac adapter and potential follow-up actions required.

• Brand Name: OPTUM TELEHEALTH
• Type of Device: OPTUM TELEHEALTH APPLICATION
• Manufacturer (Section D): OPTUMHEALTH CARE SOLUTIONS, INC.; 1100 king street; building 6, suite 300; rye brook, ny NY 10573
• Manufacturer (Section G): OPTUMHEALTH CARE SOLUTIONS, INC.; 1100 king street; building 6, suite 300; rye brook NY 10573
• Manufacturer Contact: don matthews ; 1100 king street; building 6, suite 300; rye brook, NY 10573 ; 9149334715
• MDR Report Key: 6427774
• MDR Text Key: 70758274
• Report Number: 3010521294-2017-00001
• Device Sequence Number: 1
• Product Code: DRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 115