MAUDE Adverse Event Report: WELCH ALLYN ACUITY CENTRAL MONITORING

Model Number TERMINAL SERVER KIT-32 PORTS

Device Problems No Device Output (1435); Mechanics Altered (2984)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

Our evaluation is not yet complete.A follow up report will be submitted once the evaluation is complete.

Event Description

Welch allyn received a report from a welch allyn customer stating that their terminal server locked up and would not respond.Welch allyn considers this reportable due to the loss of centralized monitoring.The term server was rebooted and is now working.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.

Manufacturer Narrative

Welch allyn technical support trouble shooting with the customer confirmed that the terminal server was not responding and appeared to be locked up.The terminal server was rebooted and has since been functioning as expected with no additional incidents.Likely potential root causes for the customer's issue include firmware issue, loose connection, malfunction of internal/external power supply.The terminal server failed outside the 3 year period after which the dfu defines the hardware components are to be replaced.No further investigation will be conducted.

• 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: 5285366
• MDR Text Key: 33848727
• Report Number: 1316463-2015-00062
• 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,Followup
• Report Date: 12/07/2015

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: TERMINAL SERVER KIT-32 PORTS
• Device Catalogue Number: 003-0217-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2011
• 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
• Patient Outcome(s): Hospitalization