MAUDE Adverse Event Report: ESCREEN, INC. ESCREEN PRINTER; COMPUTER PRINTER

Device Problems Overheating of Device (1437); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

The device in question is a peripheral hardware unit used in conjunction with used with our ereader medical device.There was no deficiency noted with the ereader device that was connected to the printer.Investigation of this event is in progress.A supplemental report will be submitted upon completion of the investigation.

Event Description

A customer reported that their device (printer) was overheating.Specifically, it was stated that the device was hot to the touch and smoke was coming out of it.The customer subsequently confirmed that no injury occurred as a result of this issue.

Manufacturer Narrative

The complaint product was not returned.Though a root cause cannot be conclusively determined, a review of this event and other similarly reported events found that there is an overheating issue with the printer.The third-party manufacturer of the printer has been made aware of this issue for investigation.Escreen will continue to monitor and trend this issue.

• Brand Name: ESCREEN PRINTER
• Type of Device: COMPUTER PRINTER
• Manufacturer (Section D): ESCREEN, INC.; 8140 ward parkway; suite 300; kansas city MO 64114
• 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: 13935301
• MDR Text Key: 298226519
• Report Number: 3003110749-2022-00002
• Device Sequence Number: 1
• Product Code: LNX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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