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

Catalog Number 008-1000-00

Device Problem Device Operational Issue (2914)

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

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

Troubleshooting by technical support confirmed that the display is not legible.Likely potential causes for no display are blown display fuse or blown capacitor, blown fuse to power supply, or power supply malfunction.Welch allyn replaced display to customer.No further investigation will be conducted.

Event Description

Welch allyn received a report from a welch allyn customer stating that their acuity display was dim and not legible.A display that is not legible could result in the loss of patient monitoring.There was no death associated with this complaint.This report was filed in our complaint 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, INC; 4341 state street rd; p.o. box 220; skaneateles falls NY 13153 0220
• Manufacturer (Section G): WELCH ALLYN, INC; 4341 state street rd; p.o. box 220; skaneateles fally 13153 0220
• Manufacturer Contact: edward o'neil ; 4341 state street rd; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156854100
• MDR Report Key: 7206246
• MDR Text Key: 98048021
• Report Number: 1316463-2018-00002
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/20/2017

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 Catalogue Number: 008-1000-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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