MAUDE Adverse Event Report: AMEDITECH, INC. EREADER+ HOST PC; COMPUTER

Model Number M720Q

Device Problem Excessive Heating (4030)

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

Event Date 08/02/2022

Event Type  malfunction  

Event Description

It was reported that their ereader computer had a black screen.Disconnecting and reconnecting the system, as advised by the technical services group, was unsuccessful in resolving the problem.During this troubleshooting session, it was discovered that the power supply wires were extremely hot.The customer then noted that their unit had completely died.Upon following up for additional information, it was confirmed that there were no injuries that resulted from the overheating wires.

Manufacturer Narrative

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

Manufacturer Narrative

The complaint product was not returned.The third-party manufacturer of the computer has been made aware of this power supply issue for investigation.A meditech will continue to monitor and trend this issue.

• Brand Name: EREADER+ HOST PC
• Type of Device: COMPUTER
• Manufacturer (Section D): AMEDITECH, INC.; 9940 mesa rim road; san diego CA 92121
• Manufacturer (Section G): AMEDITECH, INC.; 9940 mesa rim road; san diego CA 92121
• Manufacturer Contact: irene yasuda ; 9940 mesa rim road; san diego, CA 92121 ; 6193726179
• MDR Report Key: 15318517
• MDR Text Key: 303408666
• Report Number: 3003110749-2022-00007
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M720Q
• Device Catalogue Number: 10TCA000US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2022
• 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