MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A59102

Device Problems Charred (1086); Smoking (1585); Arcing (2583); Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 02/07/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter field service engineer replaced the isolatran/line conditioner, power harness and other associated device components (24v and 36v power supplies and power distribution board) to resolve the issue.(b)(4).

Event Description

The customer reported that they heard a popping noise was coming from the power supply side of their unicel dxc 880i synchron access clinical system.The customer noted that there was no fire and "minimal, unnoticeable" sign of smoke/odor was coming from the instrument.There was no report of injury or erroneous results occurred due to this event.The fire department was not called.

• Brand Name: UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7149613796
• MDR Report Key: 5457879
• MDR Text Key: 38987524
• Report Number: 2050012-2016-00071
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A59102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1