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

Catalog Number 6605632

Device Problem Device Emits Odor (1425)

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

Event Date 03/19/2014

Event Type  malfunction  

Event Description

The customer reported an electrical burning smell while attempting to bring the coulter® lh 750 hematology analyzer up from stand by.There were no sparks, arcs, smoke or flames associated with this event.The customer did not call the fire department, the fire extinguisher was not needed, and the laboratory was not evacuated.There was no report of injury or affect to patient treatment in connection with this event.The customer believed that the burning smell originated from the pneumatic power supply.The customer powered off the instrument and unplugged the power cable.

Manufacturer Narrative

A field service engineer (fse) was dispatched to the customer's site.The fse evaluated the instrument and discovered electrical burns on the bulk power supply and power filter board.The fse stated that the burned component was a coil on the power filter board in the power supply module.The fse replaced the entire power supply module to eliminate any potential issues.The fse is unsure of why the component failed, but stated that the unit is eight (8) years old.There was no indication of excessive dust or evidence of tampering.The power supply is located within a metal enclosure and is in an area inaccessible to a user.The lh 750 analyzer conforms to the (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: 3758003
• MDR Text Key: 4481380
• Report Number: 1061932-2014-00864
• 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: 03/19/2014

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
• Other Device ID Number: SW VERSION 2D3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2004
• 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