MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL, INC. ACUITY CENTRAL MONITORING

Model Number LANTRONIX 16-PORT

Device Problem Connection Problem (2900)

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

Event Date 09/24/2014

Event Type  malfunction  

Event Description

The customer stated their hard-wired pt monitors lost connection with acuity central station.The customer's biomed investigated the issue and found that terminal server was locked up.The customer's biomed power cycled the terminal server which restored normal operation.This event resulted in a temporary inability to centrally monitor patients.There was no report of any pt harm as a result of this event.

Manufacturer Narrative

Welch allyn tech support remotely accessed the customer's acuity system and confirmed the terminal servier had stopped working.The log files also indicated that "check network" message appeared on the screen indicating a loss of communications.The customer elected not to return the terminal server to welch allyn.The customer decided to monitor their terminal server to see if the issue reoccurs.A terminal servier is an off-the-shelf computer peripheral made by another mfr and sold by welch allyn.

• Brand Name: ACUITY CENTRAL MONITORING
• Manufacturer (Section D): WELCH ALLYN PROTOCOL, INC.; 8500 s.w. creekside place; beaverton OR 97008 710
• Manufacturer Contact: robert berry ; 8500 s.w. creekside place; beaverton, OR 97008-7107 ; 5035307500
• MDR Report Key: 4230544
• MDR Text Key: 4970656
• Report Number: 3023750-2014-00027
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LANTRONIX 16-PORT
• Device Catalogue Number: 700-0036-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1