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

Model Number ACUITY 8.20.01

Device Problems Failure to Power Up (1476); Self-Activation or Keying (1557)

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

Event Date 11/27/2014

Event Type  malfunction  

Event Description

The customer reported their acuity system unexpectedly rebooted.This resulted in a temporary inability to centrally monitor patients, however bedside monitoring was not affected.Welch allyn engineering evaluation of the acuity log files shoes that acuity system ta02643 had xid error, which indicates nvidia nvs-510 video card hardware issue.Acuity behaved as designed.There was no report of any patient harm as a result of the reported event.

Manufacturer Narrative

Nvidia video card is an off-the-shelf computer peripheral made by nvidia.Nvidia card evaluation is not yet complete.A f/u report will be submitted when the evaluation is complete.The customer received a replacement system.

• Brand Name: ACUITY CENTRAL MONITORING
• Type of Device: DSI
• 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: 4358081
• MDR Text Key: 5203744
• Report Number: 3023750-2014-00037
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/27/2014

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: 11/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2014
• 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