MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 750 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number A85570

Device Problems Fire (1245); Device Emits Odor (1425); Smoking (1585); Arcing (2583); Sparking (2595)

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

Event Date 12/09/2014

Event Type  malfunction  

Event Description

A beckman coulter field service engineer (fse) reported a burning smell, smoke, sparks, arcs and flames from the customer's coulter lh 750 hematology analyzer, during validation and installation of the instrument.The customer was not using the instrument at the time of the incident and there was no report of erroneous results associated with this incident.The fire department was not called.There was no report of injury to the operator.

Manufacturer Narrative

(b)(4).The fse replaced the pneumatic power supply on the instrument to resolve the issue.The fse attributed the issue to varistors located within the power supply.The varistors are enclosed within the power supply cabinet and would not cause a fire hazard to the outside of the instrument.The coulter lh 750 hematology analyzer is compliant with electrical safety standards (b)(4).(b)(4).

• Brand Name: COULTER LH 750 HEMATOLOGY ANALYZER
• 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 boulevard; brea, CA 92821 ; 7149614941
• MDR Report Key: 4377995
• MDR Text Key: 5240398
• Report Number: 1061932-2015-00017
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K061574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A85570
• Other Device ID Number: SOFTWARE VERSION 2D3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• 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