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

Model Number ACUITY

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599)

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

Event Date 06/12/2015

Event Type  malfunction  

Event Description

Welch allyn customer reported their acuity system froze up.Welch allyn technical service advised the customer's biomed to restart the system.Upon restart, the acuity system could not boost past the console login screen.Additionally, welch allyn technical support advised the customer's biomed to reset the graphics card, which did not help to boot the system.Welch allyn replaced the cpu.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's customer, (b)(6)) reported acuity system (b)(4) was locked up/unresponsive.Welch allyn engineering determined the root cause to be due to the nvidia 290 video card.Welch allyn replaced the cpu, which restored centralized monitoring.

• Brand Name: ACUITY CENTRAL MONITORING
• Manufacturer (Section D): WELCH ALLYN PROTOCOL, INC.; 8500 sw creekside place; beaverton OR 97008 7107
• Manufacturer (Section G): WELCH ALLYN INC; 4341 state street rd; po box 220; skaneateles falls NY 13153 0220
• Manufacturer Contact: pearley bhambri ; 4341 state street rd; po box 220; skaneateles falls, NY 13153-0220 ; 3156852568
• MDR Report Key: 4898737
• MDR Text Key: 6834327
• Report Number: 1316463-2015-00030
• 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: 06/12/2015

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: 8.10.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2015
• Initial Date FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2005
• 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