MAUDE Adverse Event Report: WELCH ALLYN ACUITY CENTRAL MONITORING

Model Number ARUBA 3200 CONTROL

Device Problems Intermittent Continuity (1121); Adverse Event Without Identified Device or Use Problem (2993); Operating System Becomes Nonfunctional (2996)

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

Event Date 03/17/2015

Event Type  malfunction  

Event Description

Welch allyn customer reported intermittent connectivity between pt monitor and their acuity central station.Welch allyn technical service determined that aruba controller was intermittently freezing up and needed to be power cycled to restore operation.Welch allyn replaced the aruba controller.

Manufacturer Narrative

Our eval of this incident is not yet complete.A follow up report will be submitted when the eval is complete.

Manufacturer Narrative

Welch allyn customer, (b)(6) reported intermittent wireless connection between pt monitors and acuity central station.The customer stated that after a reboot, their wireless controller works fine for about 4-6 weeks and the issue happens again.Welch allyn technical support requested assistance from welch allyn's wireless networking expert.After troubleshooting with the customer, wireless controller was replaced.There have been no issues with wireless connections since the controller was replaced.Engineering log file and configuration file analysis did not show any errors.The root cause could not be determined.

• Brand Name: ACUITY CENTRAL MONITORING
• Manufacturer (Section D): WELCH ALLYN; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer Contact: pearley bhambri, ra director ; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4687647
• MDR Text Key: 5691020
• Report Number: 1316463-2015-00020
• 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,health professional,use
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/17/2015

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: ARUBA 3200 CONTROL
• Device Catalogue Number: 712847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2007
• 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