MAUDE Adverse Event Report: BECKMAN COULTER WALKAWAY 40 PLUS; INSTRUMENT FOR AUTO READER & INTERPRETATION OF OVERNIGHT SUSCEPT. SYSTEMS

Model Number N/A

Device Problems Fire (1245); Device Emits Odor (1425)

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

Event Date 06/28/2015

Event Type  malfunction  

Manufacturer Narrative

The minuteman ups was not returned to the manufacturer for evaluation.It was reported that the facility biomedical engineer opened the minuteman ups and observed accumulated lint which is likely the material that ignited.The specification of the temporary and the replacement ups installed by the facility biomedical engineer was not provided to the manufacturer.It was a non microscan ups and not supported by beckman coulter.A microscan minuteman ups specification was provided to the customer.The manufacturer customer technical support explained that ups with less than 2000w would not support the walkaway instrument.At the time of the event, it was reported that the customer was loading 4-panels into the walkaway.The manufacturer customer technical support (cts) recommended connecting the instrument to the emergency line however the customer declined.The customer agreed to the cts recommendation to set up the 4-panels that were currently being loaded, add oil manually and incubate offline in an external incubator at 35°c for 18 hours, dispense the reagents next day and perform manual read.No further action is required.(b)(4).

Event Description

It was reported that burning smell emanating from the minuteman ups was noted and then it caught fire.The fire immediately extinguished.The operator immediately powered down the computer and the walkaway instrument.There was no damage observed to the instrument.The facility biomedical engineer supplied a temporary ups to be connected only to the labpro computer and not to the walkaway instrument.The biomedical engineer opened the ups and observed accumulated lint.There was no report of injury due to this event.

• Brand Name: WALKAWAY 40 PLUS
• 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: 4943124
• MDR Text Key: 23002589
• Report Number: 2919016-2015-00098
• Device Sequence Number: 1
• Product Code: LRG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911400
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Report Date: 06/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: B1018-283
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2013
• 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