MAUDE Adverse Event Report: BECKMAN COULTER LH AUTOMATION BASE UNIT; EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC

Catalog Number 988609

Device Problem Device Emits Odor (1425)

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

Event Date 08/01/2014

Event Type  malfunction  

Event Description

The customer reported a burning smell coming from the lh automation base unit.There was no report of injury.There was no report of visible flame or smoke.The fire department was not called.The customer was wearing a lab coat, gloves and eye protection.The laboratory has a risk exposure plan.

Manufacturer Narrative

A field service engineer (fse) was dispatched and evaluated the device.The fse confirmed a burnt conveyor interconnect harness and replaced it to resolve the issue.(b)(4).

• Brand Name: LH AUTOMATION BASE UNIT
• Type of Device: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDIC
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 800
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 800
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821-8000 ; 7149614941
• MDR Report Key: 4032751
• MDR Text Key: 4721877
• Report Number: 2050012-2014-00401
• Device Sequence Number: 1
• Product Code: LXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS I EXEM
• 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: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 988609
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2014
• Initial Date FDA Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2003
• 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