MAUDE Adverse Event Report: WELCH ALLYN ACUITY CENTRAL MONITORING

Model Number ACUITY CPU

Device Problem Device Operational Issue (2914)

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

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

Welch allyn field service engineer confirmed the customers allegation of the acuity having an on screen message of no video signal.Reboot of the system was unsuccessful.The cpu was replaced for the customer and the device is working without issue.The cpu is outside of the 3 year period after which the dfu defines the hardware components are to be replaced.Some potential root causes of the customers issue is a motherboard failure, processor failure.No further investigation will be conducted.

Event Description

Welch allyn received a report from a welch allyn customer stating that their acuity system was giving an error message of no video signal.When trying to restart the system, it would not reboot.A cpu failure could result in the loss of centralized monitoring.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).The customer did not provide any patient information.

• Brand Name: ACUITY CENTRAL MONITORING
• Type of Device: ACUITY
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer (Section G): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer Contact: amy forbes ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852597
• MDR Report Key: 6300521
• MDR Text Key: 66482319
• Report Number: 1316463-2017-00002
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/25/2016

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: ACUITY CPU
• Device Catalogue Number: ACUITY CPU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2011
• 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