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

Model Number TRIPP LITE DVI EXT

Device Problems Loose or Intermittent Connection (1371); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/26/2014

Event Type  malfunction  

Event Description

The customer reported display failure due to power adapter not working for tripp lite dvi link signal extender.Welch allyn replaced the tripp lite dvi link extender.Tripp lite link signal extender increases the distance a dvi signal can be transmitted.It supports video resolutions up to 2560 x 1600 @60hz, and a maximum distance of 150 ft.From the source.The customer elected not to return the tripp lite dvi link signal extender to welch allyn.Welch allyn acuity engineer assisted the customer's biomed with evaluating the dvi signal extender.It was found that the power adapter was unseated and appeared loose.Tripp lite dvi link signal extender had been replaced by welch allyn.Engineering confirmed that the power adapter was seated correctly and new signal extender performs as intended.There was no report of any patient harm as a result of the reported event.

Manufacturer Narrative

The customer did not provide any patient info.Our evaluation of this incident is not yet complete.A f/u report will be submitted when the evaluation is complete.

• 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: 4423620
• MDR Text Key: 5277729
• Report Number: 3023750-2015-00001
• 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: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TRIPP LITE DVI EXT
• Device Catalogue Number: B120-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2005
• 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