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); Smoking (1585); Arcing (2583); Sparking (2595); Electrical Shorting (2926); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to evaluate the instrument.Fse reported the power cable harness was partially charred.Fse replaced the isolatran, its power supply, and the power cable harness to resolve the issue.(b)(4).

Event Description

The customer reported the unicel dxc 600i synchron access clinical system generated "voltage generated by the smart module is out of range" errors.Customer reported hearing popping sound from the back of the instrument.There was burning smell and visible smoke.Customer also reported possible arcing/sparks.No visible flames reported.No erroneous results and exposure reported.Fire department wasn't 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 CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5391968
• MDR Text Key: 36850032
• Report Number: 2050012-2016-00031
• 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: 01/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• 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: 01/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2010
• 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