MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A27318

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

Patient Problem No Patient Involvement (2645)

Event Date 08/03/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter field service engineer found the harness and the connector to the isolatran were burnt.The fse replaced the isolatran to resolve the issue.(b)(4).

Event Description

The customer reported that they noticed a burning smell and a popping sound coming from the unicel dxc 600i synchron access clinical system while the she was performing calibration.There was no report of visible smoke, sparks or flame.There was no exposure and no injury due to this event.There were no erroneous results generated due to this event.The fire department was not called.

• Brand Name: UNICEL DXC 600I 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: 5876590
• MDR Text Key: 52555335
• Report Number: 2050012-2016-00275
• 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: 08/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A27318
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2011
• 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