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 01/09/2015

Event Type  malfunction  

Event Description

The customer reported a burning smell coming from the lh automation base unit.There was no report of visible smoke, no exposure or injury occurred due to this event.No erroneous results generated.The laboratory has a risk management plan in place.

Manufacturer Narrative

The facility's bio-medical engineer evaluated the device and replaced the burnt power wire harness connected to the lh automation inlet module to resolve the issue.Internal beckman coulter identifier is (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 92821 800
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd; brea 92821 800
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7142649714
• MDR Report Key: 4484140
• MDR Text Key: 5333275
• Report Number: 2050012-2015-00040
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/09/2015

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: 01/09/2015
• Initial Date FDA Received: 02/04/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2003
• 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