MAUDE Adverse Event Report: BIOMÉRIEUX, INC. VTK2 60 BLUE MOD COLORM 220V - 27226

Model Number 27226

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

An internal complaint was initiated in response to a malfunction of a vitek® 2 vtk2 60 blue mod colorm 220v (ref 27226, serial (b)(4) ).The instrument is an internally owned biomérieux instrument located at the (b)(6).The instrument is used for internal testing and training purposes.The instrument was being tested to verify proper function after relocating the instrument.Local customer service (lcs) notified global customer service (gcs) of an issue in which the instrument would not turn on and the fuse blows after replacement.This issue was corrected by replacing the step down transformer.An additional issue was identified with the dc power supply board.A capacitor on the dc power supply board was found to be burned and emitting smoke until power was turned off.Lcs was able to confirm that this issue did not cause or lead to any injuries.There were no patients involved with this incident.A biomérieux internal investigation will be initiated.

Manufacturer Narrative

An internal complaint was initiated in response to a malfunction of a vitek® 2 vtk2 60 blue mod colorm 220v (ref 27226, serial (b)(6) ).The instrument is an internally owned biomérieux instrument located at the china subsidiary in shanghai.The instrument is used for internal testing and training purposes.The instrument failed to startup even though the green led on the board was on, there was no motor movement.After voltage measurement was taken, it was discovered that the dc power supply board capacitor was burning.There was smoke visible and flames which stops after the power was turned off.No one was injured.The cause of the original issue (instrument sn (b)(6) user interface screen was not on and there was a startup failure) could not be determined.Proposed corrective/preventive actions ¿ corrective: in the event of an ac fuse failure, ensure the properly rated ac fuse is installed in the power entry module.In the event of an instrument power failure resulting in a suspected toroid step down transformer issue, replace the power supply drawer assembly.In the event of a dc power supply printed circuit board assembly (pcba) failure, replace the pcba.(reference: vitek 2 and vitek 2 xl integrated system service manual 049292-01.) biomérieux investigator could not confirm a root cause.

• Brand Name: VTK2 60 BLUE MOD COLORM 220V - 27226
• Type of Device: VTK2 60 BLUE MOD COLORM 220V - 27226
• Manufacturer (Section D): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer (Section G): BIOMÉRIEUX, INC.; 595 anglum road; hazelwood MO 63042
• Manufacturer Contact: jeff scanlan ; 595 anglum road; hazelwood, MO 63042
• MDR Report Key: 11792641
• MDR Text Key: 273359309
• Report Number: 1950204-2021-00036
• Device Sequence Number: 1
• Product Code: LON
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N50510/082
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 27226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1