MAUDE Adverse Event Report: WELCH ALLYN PROTOCOL, INC. ACUITY CENTRAL MONITORING

Model Number ACUITY

Device Problems Loose or Intermittent Connection (1371); Computer Operating System Problem (2898)

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

Event Date 04/16/2015

Event Type  malfunction  

Event Description

Welch allyn customer says their acuity system is rebooting itself unexpectedly; they have experienced multiple reboots.There was no report of any patient harm as a result of the reported event.The customer did not provide any patient information.

Manufacturer Narrative

The device evaluation is not yet complete.A follow-up report will be submitted, when the evaluation is complete.

Manufacturer Narrative

Welch allyn customer reported multiple unexpected reboots on their acuity system, resulting in a loss of centralized monitoring.Welch allyn field service engineer visited the customer site and extracted system log files.Acuity software engineer evaluated the log files and determined there have been 17 unexpected reboots.Engineering log file analysis points to cspm (central station print manager) where it was issuing errors regarding printing pdf documents due to wacs (welch allyn connectivity server) not maintaining a continuous connection to acuity system.The pdf printer option was disabled within the configuration file.This prevented issuing of pdf printouts to an unavailable wacs and as result stopped unexpected reboots from occurring.Removing the pdf printer option restored centralized monitoring and prevented unexpected reboots.Subsequently, the customer elected to keep this as a permanent option and discontinue further troubleshooting.There have been no further complaints for this issue from this customer for the two months since then.

• Brand Name: ACUITY CENTRAL MONITORING
• Manufacturer (Section D): WELCH ALLYN PROTOCOL, INC.; 8500 sw creekside place; beaverton OR 97008 7107
• Manufacturer Contact: pearly bhambri, ra director ; 4341 state st. rd.; p.o. box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4731297
• MDR Text Key: 5736001
• Report Number: 1316463-2015-00017
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052160
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• 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: 8.10.01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2012
• 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