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

Catalog Number 6605632

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425)

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

Event Date 01/30/2015

Event Type  malfunction  

Event Description

While servicing a coulter lh 750 hematology analyzer at a customer site, the field service engineer (fse) observed a burn smell from the instrument and a burn mark on the power supply cable.There was no report of smoke, flames or arcing; a fire extinguisher was not used and the fire department was not called in connection with this event.There was no injury associated with the event.

Manufacturer Narrative

The fse discovered a loose t-fitting inside the power supply for the 60 psi pressure.The pneumatic power supply was replaced, resolving this issue.The fse replaced the power supply cable that connects the wall outlet to the power supply, resolving this issue.(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 ave; miami FL 33196
• Manufacturer Contact: miranda holland ; 11800 sw 147th avenue, 32-l23; miami, FL 33196 ; 3053802031
• MDR Report Key: 4573275
• MDR Text Key: 5559009
• Report Number: 1061932-2015-00387
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• 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: 01/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2005
• 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