MAUDE Adverse Event Report: BECKMAN COULTER LABPRO COMPUTER; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS

Model Number N/A

Device Problems Fire (1245); Smoking (1585)

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

Event Date 04/23/2015

Event Type  malfunction  

Event Description

It was reported that the labpro aegis computer used with walkaway instruments started smoking and produced a small amount of flames coming from the vent of the computer.A laboratory technician extinguished the flame and smothered the flame.No fire extinguisher was needed.Building facilities removed the computer from the lab.No power surges were observed prior to the event.It was reported that the panels already loaded onto the two walkaway instruments were read manually.There were no reports of injuries or adverse events as a result of this incident.

Manufacturer Narrative

Labpro computer is not a medical device and is used in conjunction with the walkaway instrument.The computer was returned for evaluation and it was determined, that dust accumulated due to the computer's electronic failure, likely started the smoke and resulted into the flame.The mother board failed and no additional testing could be performed.The manufacturer's field service engineer replaced the damaged computer and installed the required labpro software.The replacement computer was tested with the walkaway instruments and results met the performance specifications.Beckman coulter internal identified for this report is (b)(4).

• Brand Name: LABPRO COMPUTER
• Type of Device: INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS
• Manufacturer (Section D): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer (Section G): BECKMAN COULTER; 2040 enterprise blvd; west sacramento CA 95691
• Manufacturer Contact: norma rahill ; 1584 enterprise blvd; west sacramento, CA 95691 ; 9163742139
• MDR Report Key: 4789565
• MDR Text Key: 18892930
• Report Number: 2919016-2015-00060
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: B1018-510
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1