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

Model Number ARUBA 6000

Device Problems Computer Operating System Problem (2898); Device Operational Issue (2914)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Welch allyn customer alleged wireless dropouts on multiple acuity systems.The customer's biomed said it happened twice.Once around 12:06 and again at 12:11.Both times it lasted for about a minute.Welch allyn technical support remotely logged into the customer's system and determined that the aruba wireless controller had unexpectedly rebooted.

Manufacturer Narrative

Welch allyn technical support confirmed the customer allegation of an unexpected reboot.The customer did not return the aruba controller for evaluation.Likely potential causes of a controller reboot may be due to firmware issue, loose connection, unplugged connection, or malfunction of internal/external power supply.No further investigation will be conducted.

• Brand Name: ACUITY CENTRAL STATION
• Type of Device: ACUITY
• Manufacturer (Section D): WELCH ALLYN, INC; 4341 state street road; skaneateles falls NY 13153 4341
• 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: 5024991
• MDR Text Key: 24705597
• Report Number: 1316463-2015-00037
• 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: Other
• Type of Report: Followup
• Report Date: 08/07/2015

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: No Information
• Device Model Number: ARUBA 6000
• Device Catalogue Number: 104630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 7 YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2008
• 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