MAUDE Adverse Event Report: WELCH ALLYN, INC. ACUITY CENTAL MONITORING; DSI

Model Number ACUITY

Device Problems Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996)

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

Event Date 05/07/2015

Event Type  malfunction  

Event Description

Welch allyn customer reported intermittent wireless connectivity between patient monitors and their acuity central station.Welch allyn tech service along with the wireless controller mfr are assisting the customer in restoring normal operation.

Manufacturer Narrative

Our evaluation of this incident is not yet complete.A f/u report will be submitted when the evaluation is complete.

Manufacturer Narrative

Engineering analysis of (b)(4) controller logs shows issues detected due to loss of power when the customer power cycled the controller to restore wireless communications.Welch allyn requested assistance from (b)(4) network to send their engineer to customer site.(b)(4) engineer was not able to find any problems with the controller itself so he went searching in (b)(4) networks own failure/bug database.He said that there were some similar issues that had been reported in the past with similar versions of the os (operating system) that had been corrected by an os update from the old version to 5.0.3.3.Since the update to the controller, they have not had a freeze-up.

• Brand Name: ACUITY CENTAL MONITORING
• Type of Device: DSI
• Manufacturer (Section D): WELCH ALLYN, INC.; 4341 state st. rd.; skaneateles falls NY 13153
• Manufacturer (Section G): WELCH ALLYN, INC; 4341 state street road; skaneateles falls NY 13153 4341
• Manufacturer Contact: pearley bhambri ; 4341 state street road; p.o box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4809179
• MDR Text Key: 5892282
• Report Number: 1316463-2015-00026
• 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
• Report Date: 05/07/2015

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: ACUITY
• Device Catalogue Number: 712847
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2015
• Initial Date FDA Received: 05/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2006
• 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