MAUDE Adverse Event Report: ECREEN INC. EREADER; DRUG SCREENING PLATFORM

Model Number	V3
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 23-jun-2021, the escreen product analysis lab (pal) received the ereader¿ for evaluation.No power supply was returned with the ereader¿.Upon receipt, visusal inspection of the ereader¿ was performed.The ereader¿ had no scorch marks, melting, or any other signs of damage on the plastic or the main board pcb, but was non functional.A request for return of the power cord was completed and currently pending.A followup report will be submitted upon receipt of the power cord and completion of the investigation of the ereader¿.The device history record was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures a historical review was performed on 14-jul-2021 for all related complaints regarding melted components.The timeframe selected was from 01jun2018 to 01jun2021 (minimum of 3 years prior to the issue being observed; 2 years=maximum shelf life of any esc product and 1 year=due diligence).See keywords below that defined this historical search.Keywords: ereader and melt 0 additional cases beyind this one were identified.
Event or Problem Description
On (b)(6) 2021, complaint (b)(4) was received.The customer reported that "the power cord/ box for their escreen ereader¿ has melted".No adverse patient consequences were reported.This event has conservatively been assessed as an mdr reportable malfunction pending additional investigation.
Additional Manufacturer Narrative
Corrected data: d2, g1, h6.Though the ereader unit was returned, the power supply adapter was not returned for evaluation.Though a root cause cannot be conclusively determined, a review of this event and other similarly reported events found that the issue may be attributed to the manufacturer of the power supply adapter.The issue has been escalated for further review and investigation.Escreen will continue to monitor and trend this issue.

• Brand Name: EREADER
• Common Device Name: DRUG SCREENING PLATFORM
• Manufacturer (Section D): ECREEN INC.; 1725 w williams dr; bldg f67&68; phoenix AZ 85027
• Manufacturer (Section G): ESCREEN, INC.; 8140 ward parkway; suite 300; kansas city MO 64114
• Manufacturer Contact: christel parsons ; 8140 ward parkway; suite 300; kansas city, MO 64114 ; 8164017246
• MDR Report Key: 12181690
• Report Number: 3004129879-2021-49613
• Device Sequence Number: 2771827
• Product Code: JJQ
• UDI-Device Identifier: 00867802000207
• UDI-Public: 00867802000207
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V3
• Device Catalogue Number: 207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown