MAUDE Adverse Event Report: BECKMAN COULTER COULTER ACT DIFF 2 ANALYZER; COUNTER, DIFFERENTIAL CELL

Catalog Number 6605500

Device Problem Device Emits Odor (1425)

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

Event Date 02/22/2015

Event Type  malfunction  

Event Description

While a field service engineer (fse) was installing a vacuum pump on a coulter act diff 2 analyzer, the fse noticed a burn smell coming from the pump upon activation.There was no fire or smoke associated with the event.The fse or customer did not observe sparks, arcs, and flames.A fire extinguisher was not used and the fire department was not called in connection with this event.Erroneous patient results were not generated and there was no change or affect to patient treatment in connection with this event.

Manufacturer Narrative

The fse confirmed the vacuum pump never accumulated 6 inhg in the proper amount of time and was defective.The fse replaced the part resolving the issue.(b)(4).

• Brand Name: COULTER ACT DIFF 2 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: 4615151
• MDR Text Key: 5701846
• Report Number: 1061932-2015-00481
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990352
• 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: 02/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6605500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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