MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM; COUNTER, DIFFERENTIAL CELL

Catalog Number 629029

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Failure to Power Up (1476); Smoking (1585)

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

Event Date 11/07/2014

Event Type  malfunction  

Event Description

While servicing a unicel dxh 800 coulter cellular analysis system in a customer's facility on (b)(6) 2014, a beckman coulter field service engineer (fse) replaced the power supply to address a noisy fan, initially reported by the customer on (b)(6) 2014.After replacing the power supply, the analyzer would not function, i.E.Would not power on.The fse observed smoke from the top of the analyzer, and a burnt odor.The fse identified a burned out chip on the card cage as the cause of the smoke and burnt odor.The fse acquired another power supply and repaired the analyzer on (b)(6) 2014.There were no arcs, sparks of flames observed for this event and the fire department was not called.There was no death, injury, or change to patient treatment or user safety attributed to or connected with this event.

Manufacturer Narrative

On (b)(4) 2014, a beckman coulter field service engineer (fse) evaluated the analyzer and replaced the electrical power supply and the card cage resolving the reported issue.(b)(4).

• Brand Name: UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
• Type of Device: COUNTER, DIFFERENTIAL CELL
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 11800 sw 147th avenue; miami FL 33196
• Manufacturer Contact: dung nguyen ; 250 s kraemer blvd; brea, CA 92821 ; 7149614941
• MDR Report Key: 4301955
• MDR Text Key: 5268817
• Report Number: 1061932-2014-02948
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081930
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Catalogue Number: 629029
• Other Device ID Number: SOFTWARE VERSION: 2.0.2.1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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