MAUDE Adverse Event Report: BIOMERIEUX, INC. VITEK 2 HP RP5800; VITEK® 2 HP RP5800

Model Number 413862

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Event Description

A customer in (b)(6) notified biomérieux of fumes and smoke emitting from their vitek® 2 compact system, hp rp5800 pc wes7 (ref.413862, serial number (b)(4)) when attempting to power on the instrument.The customer stated they were able to power on the instrument after repeated mashing of the power button, and suspected a failing power supply or possible ups malfunction.The vitek® 2 hp rp5800 pc wes7 (ref.413862, serial number (b)(4)) did not switch on for a few days, the customer then connected the computer to the main power supply using a 5 amp iec cable.The customer then attempted to restart the computer while the case was open, smoke was observed coming from the instrument.The customer then noticed a motherboard component glow orange then burn out.The instrument was then powered off and removed from use.Biomerieux has scheduled a visit by a field application specialist to service and repair the customer¿s instrument.There is no indication that the smoking instrument lead to any adverse event related to any person¿s state of health.Biomerieux will initiate an internal investigation.

Manufacturer Narrative

This report was initially submitted following notification from a customer in the (b)(6) regarding fumes and smoke emitting from their vitek® 2 hp rp5800 pc wes7 (ref.413862, serial number czc51622fn) when attempting to power on the instrument.The customer reported issues getting the pc to power on over multiple days and suspected a failing power supply or ups issue.The pc was connected to the main power supply via a 5 amp iec cable.Smoke was observed coming from the pci 2-port rs-232 serial interface (part: 7202 -2249 model: comm+232.Pci) which was connected to the 2-slot pci riser card (hp assy p/n 640265-001).Shortly after the observation of smoke, an electronic component on the motherboard glowed orange and burned out.The pc was not returned to biomerieux for the investigation.Potential root causes of the power supply unit failure include the following: overheating caused by excess dust/dirt collected inside the pc over time, including the power supply unit and interface parts.Removing the ups and connecting the pc directly to the main power supply which would eliminate filtering of the voltage going into the pc.An electronic component inside the pc reached its life span causing the pc to fail.It was not possible to confirm any of these potential causes because the impacted pc was discarded at the customer site and not returned for evaluation.Biomerieux recommends that vitek® 2 systems be maintained according to the existing preventive maintenance (pm) procedures (vitek 2 systems ¿ preventive maintenance procedure, 049294-1).The pm includes instructions for the field service engineer (fse) to clean the pc to minimize dust accumulation that could lead to internal heat buildup and premature component failure.

• Brand Name: VITEK 2 HP RP5800
• Type of Device: VITEK® 2 HP RP5800
• Manufacturer (Section D): BIOMERIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMERIEUX INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: tenika rhodes ; 100 rodolphe street; durham, NC 27712
• MDR Report Key: 10892362
• MDR Text Key: 245597522
• Report Number: 1950204-2020-00204
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K050002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 413862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1