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

Model Number ACUITY

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/27/2015

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's (b)(4) distributor (b)(4) reported that their customer, (b)(6) experienced wireless dropout on acuity central station.The clinical staff noticed that the system was not connected to the network at the moment they wanted to connect a patient to a bedside monitor.There were no patients connected at the time the issue occurred.The customer did not provide any patient information.

Manufacturer Narrative

Welch allyn technical support was not able to confirm the customer complaint of a dropout on the acuity central station.The customer did not return the aruba controller for evaluation.Likely potential causes of a controller failure may be due to firmware issue, loose connection, malfunction of internal/external power supply.No further investigation will be conducted.

• Brand Name: ACUITY CENTRAL MONITORING
• Type of Device: ACUITY CENTRAL STATION
• Manufacturer (Section D): WELCH ALLYN, INC; 4341 state street road; skaneateles falls NY 13153
• 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: 5021954
• MDR Text Key: 24685481
• Report Number: 1316463-2015-00038
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K052160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUITY
• Device Catalogue Number: 104630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: 18 MO
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2014
• 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