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

Catalog Number 6605632

Device Problems Melted (1385); Device Emits Odor (1425)

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

Event Date 03/21/2014

Event Type  malfunction  

Event Description

The customer reported a burning smell from the coulter lh 750 hematology analyzer and noticed that the plug at the rear of main power supply appeared melted/hot.There were no sparks, fire, smoke or flames observed and the customer noticed only a burning smell.The customer did not evacuate the laboratory nor call the fire department.There was no report of injury associated with this event.Erroneous results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

A beckman coulter field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and discovered that the end of the power cord connected to the power supply was a bit loose.The fse noted that the power cord must have loosened itself and was slightly melted.The fse proceeded to replace the power cord and connector to repair the instrument.(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: 3755187
• MDR Text Key: 4415202
• Report Number: 1061932-2014-00848
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2006
• 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