MAUDE Adverse Event Report: WELCH ALLYN ACUITY CENTRAL MONITORING

Model Number BLADE 150

Device Problems Self-Activation or Keying (1557); Insufficient Information (3190)

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

Event Date 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Welch allyn customer says their acuity system rebooted itself unexpectedly, resulting in a temporary loss of centralized monitoring.There was no report of any patient harm as a result of the reported event.

Manufacturer Narrative

Trouble shooting by welch allyn technical support was not able to confirm the customers allegation of a reboot.The cpu was not returned for investigation, and there were no log files sent for analysis.The likely root cause of the customers issue could be a failure due to a bad hard drive, bad video card, a motherboard failure, or a ram failure.No further investigation will be conducted.

• Brand Name: ACUITY CENTRAL MONITORING
• Type of Device: ACUITY
• Manufacturer (Section D): WELCH ALLYN; 4341 state street road; p.o. box 220; skaneateles falls NY 13153 0220
• 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: 5173857
• MDR Text Key: 29838951
• Report Number: 1316463-2015-00052
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 10/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BLADE 150
• Device Catalogue Number: ACUITY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2005
• 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