MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC VENTANA HE 600 SYSTEM; SLIDE STAINER, AUTOMATED

Catalog Number 06917259001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

Upon visiting the site, the local field service engineer opened the front and back instrument panels.Upon inspection, there was evidence of short circuit on pmad (power management and distribution board), that caused the burn and fusion of connector and cable connection.The instrument is being returned for further inspection.An investigation has commenced.A supplemental report will be submitted once investigation conclusions are available.(b)(4).

Event Description

An (b)(6) customer reported that after turning on the he 600 system, there was a burning smell and several instrument errors were displayed.No harm or injury was indicated.

Manufacturer Narrative

Based on images shared from the site, the instrument was connected to the facility's ventilation system.Review of physical evidence shows that the event originated from the upper right compartment (when viewed from the front) containing the pmad circuit board, moxa serial hub, 24 vdc power supply, and sco circuitry.Close inspection shows that the event originated at the pmad circuit board.Removal of the board and laboratory inspection shows evidence of greatest damage at the connection around the reagent connector (j15) with damage to pins on the board side in the middle of the connector.At this location, the following potential failure modes could be expected to contribute to the cause of the event: contamination during or after manufacture; a solder or board defect; incidental damage that occurred after manufacturing.Due to the effects of the event on the board, the connections at the point of origin were too damaged to be able to effectively determine the cause beyond the proposed failure modes outlined above.The burning spread from the point of origin by way of stray voltage applied through the board during thermal degradation of the materials.Once the power was removed from the equipment, it appears to have self-extinguished, consistent with material design (pcb and cable connectors are ul94-v0), and damage was limited to the pmad circuit board and connected cables.Current loads for cables, connectors, and board components were reviewed.The analysis of each cable used in the he600 that carries 24 vdc or 65 vdc from the pmad is shown to have appropriate design considerations for the expected current carrying capacity and voltage used in the wires.There is no safety risk of wire undersizing that may lead to safety incidents over inappropriate cabling design under normal instrument operation.The pmad has modular specific circuit overcurrent protection, which can protect against shorts and over current events on connected modules and cables while the system is running.The he600 system installation manual indicates that the ventana he600 system should be vented.The ventana he 600 system will utilize venting for evacuation of fumes (limonene, glycols, ethers) and proper thermal environment management within the system.It is recommended that ventilation is provided for the ventana he 600 instrument by connecting to the facility ventilation system.All evidence, including the investigations by the 3rd party forensic company and supplier of pcba boards, and review of escalated cases/field replacements since jan 2019, indicates that this situation is unique.Based on the active install base and pmad replacements, this one incident of a burning pmad represents 0.13% (1/773 pmads).

• Brand Name: VENTANA HE 600 SYSTEM
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• MDR Report Key: 10756661
• MDR Text Key: 213715369
• Report Number: 2028492-2020-00010
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06917259001
• Date Manufacturer Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1