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

Model Number SUN BLADE 150-650

Device Problems Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913); Operating System Becomes Nonfunctional (2996)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2014

Event Type  malfunction  

Event Description

Customer reported their acuity was down.It was showing a gray screen with no text on the display and was missing the keyboard.The customer found a keyboard and welch allyn technical support assisted the customer in troubleshooting the cpu and unsuccessfully attempting to reboot.A loaner cpu was provided to the customer.This resulted in a temporary inability to centrally monitor pts, however bedside monitoring was not affected.There was no report of any pt harm as a result of the reported event.

Manufacturer Narrative

In a follow-up interview, the customer technician said that while waiting for the loaner cpu to arrive, he determined that the hard disk drive (hdd) was faulty.The customer returned cpu to the factory for repair.Welch allyn factory service confirmed the hdd failure.The hdd was replaced and software and system files were reloaded.Testing was performed and passed.Hard disk drives are off-the-shelf sub-components made by welch allyn.Welch allyn does not possess troubleshooting capability beyond identifying these sub-components as the source of failure.Method: factory service confirmed hdd failure.

• Brand Name: ACUITY CENTRAL MONITORING
• Manufacturer (Section D): WELCH ALLYN PROTOCOL, INC.; 8500 s.w. creekside place; beaverton OR 97008 710
• Manufacturer Contact: robert berry ; 8500 s.w. creekside place; beaverton, OR 97008-7107 ; 5035307500
• MDR Report Key: 3701547
• MDR Text Key: 4338658
• Report Number: 3023750-2014-00005
• 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: User Facility,Distributor
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/28/2014

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: SUN BLADE 150-650
• Device Catalogue Number: 700-0362-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2014
• Initial Date FDA Received: 02/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2004
• 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