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

Catalog Number 06917259001

Device Problems Device Alarm System (1012); Leak/Splash (1354); Device Emits Odor (1425); Overheating of Device (1437); Material Puncture/Hole (1504)

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

Event Date 03/24/2020

Event Type  malfunction  

Manufacturer Narrative

The roche field engineer replaced the affected parts.The instrument has been fixed and handed back to the customer for operation.The device's udi number is: (b)(4).

Event Description

A customer reported that the site smelled a burning odor coming from the instrument and the instrument displayed an error message.The site evacuated the building as a precaution.A roche field service engineer (fse) went on site and found a pin-hole on the t-fitting that caused a slow leak of the he 600 cleaning solution to the compressor bay.Liquid dripped on the vent fan connector and created an electrical short that stopped the fan.Without the fan working, the compressor overheated and the elevated temperature melted the plastic fan connector that produced a burning smell and generated the error message.The engineer indicated there was no evidence of fire found and there was no harm to any users on site.The instrument has been fixed and tested by the fse, and handed back over to the customer for operation.

Manufacturer Narrative

Through the capa investigation, improvements have been made to the ventana design process, including design readiness and material compatibility work instructions and checklists.We are currently monitoring the progress of the updates made to the ventana design processes to ensure effective implementation.(b)(4).

• 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: 9972220
• MDR Text Key: 193265584
• Report Number: 2028492-2020-00005
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1