MAUDE Adverse Event Report: BECKMAN COULTER COULTER LH 500 HEMATOLOGY ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 178833

Device Problem Device Emits Odor (1425)

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

Event Date 05/08/2014

Event Type  malfunction  

Event Description

The customer reported burning odor while analyzing patient samples involving the coulter lh 500 hematology analyzer.The customer stated there was no smoke, arcs, sparks or fire, and the fire department was not requested.There was no operator injury or adverse effect associated with this event.The customer turned off the instrument and discontinued use.There was no report of impact to patient results.There was no patient injury associated with this event.A beckman coulter field service engineer (fse) was dispatched to assess the instrument.

Manufacturer Narrative

The field service engineer (fse) discovered component t1, on the printed circuit board (pcb) assembly, failed causing the burning odor.The fse replaced the differential mix motor assembly and verified instrument operation.Service activity performed was verified to meet the specified requirements per established procedures.The instrument conformed to the manufacturer's published performance specifications and was returned to normal operation.In conclusion, the likely cause of the event is attributed to the differential mix motor assembly.(b)(4).

• Brand Name: COULTER LH 500 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 blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3846556
• MDR Text Key: 4662350
• Report Number: 1061932-2014-01278
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042724
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 178833
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2014
• Date Device Manufactured: 12/01/2004
• 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