MAUDE Adverse Event Report: WELCH ALLYN ACUITY CENTRAL MONITORING

Model Number ACUITY 7.10.01

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599); Communication or Transmission Problem (2896)

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

Event Date 01/27/2015

Event Type  malfunction  

Event Description

Welch allyn customer reported loss of centralized monitoring on their acuity central station.Welch allyn technical service remotely accessed the customer's acuity system and determined loss of wireless communication between patient monitors and acuity.It was found that an aruba controller was intermittently freezing up and needed to be power cycled to restore operation.Welch allyn replaced the aruba controller.

Manufacturer Narrative

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

• Brand Name: ACUITY CENTRAL MONITORING
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; skaneateles falls NY 13153
• Manufacturer Contact: pearley bhambri, director ; 4341 state street road; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4540530
• MDR Text Key: 5514821
• Report Number: 1316463-2015-00009
• 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
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/27/2015

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 7.10.01
• Device Catalogue Number: 712847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2006
• 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