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

Model Number SONY SDM-X93 19"LCD

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 03/31/2014

Event Type  malfunction  

Event Description

The customer reported that their display failed.Welch allyn replaced the display.There was no report of any patient harm as a result of the reported events.The customer did not provide any patient info.

Manufacturer Narrative

The customer elected not to return the display to the factory.The customer's biomed independently evaluated the display on site and confirmed the failure.The acuity display is an off-the-shelf computer peripheral made by another manufacturer and sold by welch allyn.Welch allyn does not possess troubleshooting capability beyond identifying these subcomponents as the source of the failure.Method - other (customer's biomed confirmed display failure).

• 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: 3940534
• MDR Text Key: 4577743
• Report Number: 3023750-2014-00010
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052160
• 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: 03/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SONY SDM-X93 19"LCD
• Device Catalogue Number: 008-1000-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2014
• Initial Date FDA Received: 04/18/2014
• 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