MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 APC 1000 UPS

Catalog Number 27227

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

A customer reported to biomerieux that a fire started within the uninterruptible power supply (ups) attached to the computer for the vitek 2 instrument.The customer initially stated that the ups caught on fire.It was extinguished by laboratory personnel using a fire extinguisher.Upon further interview with the customer, it was noted that no flames were seen coming from the ups; however, smoke was noticed.Therefore the laboratory personnel used the fire extinguisher to extinguish it.No injury to laboratory personnel was incurred as a result of this event.No damage to the vitek 2 instrument nor the computer was noted as a result of the fire.Therefore, there was no impact to patient results nor a delay in results.An investigation will be initiated by biomerieux to investigate this event.

Manufacturer Narrative

A customer reported to biomerieux that a fire started within the uninterruptible power supply (ups) attached to the computer for the vitek® 2 instrument, an internal biomereux investigation was performed.Results are as follows: the investigation was initiated in response to a customer complaint reporting that their ups 1000 emitted smoke.After review of the returned ups, it was noted that a capacitor failure was the cause of the smoke.It is not unusual for a failing capacitor to emit smoke prior to it's self-destruction and removal from the power source.There was no actual danger to the operator.Complaint history and trend review do not suggest a systemic quality issue.

• Brand Name: VITEK® 2 APC 1000 UPS
• Type of Device: VITEK® 2 APC 1000 UPS
• Manufacturer (Section D): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer (Section G): BIOMERIEUX, INC; 595 anglum road; st. louis MO 63042
• Manufacturer Contact: ellen weltmer ; 595 anglum road; hazelwood, MO 63042 ; 3147317301
• MDR Report Key: 5913695
• MDR Text Key: 53477072
• Report Number: 1950204-2016-00112
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27227
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1