MAUDE Adverse Event Report: BIOMERIEUX, INC VITEK® 2 UNINTERRUPTABLE POWER SUPPLY (UPS), APC 1000; VITEK® 2 UPS

Model Number 93024

Device Problems Smoking (1585); Device Inoperable (1663); Battery Problem (2885)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr is part of the 227 pilot program.Biomérieux internal investigation has been initiated.Device not returned to manufacturer.

Event Description

This report summarizes 1 malfunction event.A customer in the united states reported smoke was issuing from the uninterruptible power supply (ups), model apc 1000, associated with the vitek® 2 system.No flames were observed; however, fire extinguishers were used on the ups.Laboratory personnel were evacuated.Fire department was contacted.The customer indicates there were no injuries or illness as a result of the smoke.Biomérieux has requested the ups be returned for investigation purposes.An internal biomérieux investigation has been initiated.

Manufacturer Narrative

This report was initially submitted 21-apr-2016 as part of the 227 pilot program (exemption number (b)(4)).Biomérieux internal investigation was initiated; however, the customer did not comply with biomérieux request to return the ups for evaluation.The ups model smt1000, from apc, (schneider electric it corporation) is ul listed (reference listing yedu.E95463) and as such meets the requirements of ansi/ul1778.Among other things ul1778: ".Specifies requirements intended to ensure safety for the operator and, where specifically stated, for service personnel.This standard is intended to reduce the risk of fire, electric shock, or injury to persons from installed equipment, both as a single unit or as a system of interconnected units, subject to installing, operating, and maintaining the equipment in the manner prescribed by the manufacturer." the probability of fire in the ups is very low and the design (for ul listing) of the ups is intended to contain any fire internally until it self extinguishes.The ups does contain electronic/electrical components that may be subjected to heavy electrical loads and severe electrical transients.The possibility of component internal failure always exists.When a component experiences an internal failure, it will generate localized high temperature, smoke/smoldering and the appearance of charring of the exterior of the component.It may become hot enough and smoke sufficiently to cause melting or discoloration of adjacent components.This is a self-destructive activity and the component will remove itself from the electrical path, which stops any further propagation of the failure and self extinguishes.The capacitor is an electrical component used in the ups to improve electrical signal and smooth electrical transients.Due to the power requirements of an ups, the capacitors can be larger in physical size then most other electronic/electrical components.These larger capacitors can emit smoke for several seconds prior to self destructing.While not a danger to the operator, it can be disconcerting and may appear to be a fire danger.This ups model is actually tested to contain these failures and not be a danger to the operator.Without the ups to inspect, it is not possible to absolutely determine the cause of smoke, but a capacitor failure is the most probable cause of the smoke and there was no actual danger to the operator.Device not returned to manufacturer.

• Brand Name: VITEK® 2 UNINTERRUPTABLE POWER SUPPLY (UPS), APC 1000
• Type of Device: VITEK® 2 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: 5596839
• MDR Text Key: 43290132
• Report Number: 1950204-2016-00047
• 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): Y
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 93024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1