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

Model Number ACUITY 8.20.01

Device Problem Connection Problem (2900)

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

Event Date 09/08/2014

Event Type  malfunction  

Event Description

The customer reported they were unable to user their keyboard.Welch allyn technical support remotely accessed the customer's acuity system and found that a sun keyboard had been plugged in on (b)(6) 2014, which subsequently caused the system to freeze.This resulted in a temporary inability to centrally monitor pts, however bedside monitoring was not affected.There was no report of any pt harm as a result of the reported event.The customer did not provide any pt info.

Manufacturer Narrative

Welch allyn engineering determined that sun usb type 7 keyboard running with the platform cpus may lead to an unexpected cpu lock up.Welch allyn investigation found that platform cpu locking up was due to the usb hubs on the sun type 7 keyboard.Sun type 7 keyboards are replaced with cherry keyboards by welch allyn technical support when this issue is determined to be the cause of acuity system problem.The customer had been using the cherry keyboard until on (b)(6) 2014 when sun keyboard was plugged in according to log files.Welch allyn reminded the customer to use cherry keyboards only.Complaint search and a follow up call with the customer after replacement of keyboard indicate there have been no further issues.

• 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: 4358175
• MDR Text Key: 5203765
• Report Number: 3023750-2014-00036
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUITY 8.20.01
• Device Catalogue Number: 102753
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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