MAUDE Adverse Event Report: VENTANA MEDICAL SYSTEMS INC BENCHMARK ULTRA STAINER MODULE; SLIDE STAINER, AUTOMATED

Catalog Number 05342716001

Device Problems Electrical /Electronic Property Problem (1198); Leak/Splash (1354)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.A follow-up report will be submitted upon the completion of the investigation.(b)(6).

Event Description

During a troubleshooting visit, the field specialist identified that the afm gpio board from the benchmark ultra instrument located at a customer in china showed evidence of charring.No harm or injury alleged.

Manufacturer Narrative

It was reported that the instrument shut down and the charring was contained.Only the board and its attached connectors/cables were impacted.The most likely root cause is fluid migration from the slide drawer affecting the gpio board.The board and the impacted connectors were replaced and no further issues were observed.The connectors on the gpio boards are ul94 compliant and are designed to self-extinguish without a separate fuel source.The design of the benchmark ultra instrument limits the chances of the spread of fire due to limited fuel available (plastic) and the fact that it is mounted to metal.The instrument was designed to and has been certified to meet the standards of iec/en 61010-1 which include section 6, protection against electric shock and section 9, protection against the spread of fire.

• Brand Name: BENCHMARK ULTRA STAINER MODULE
• Type of Device: SLIDE STAINER, AUTOMATED
• Manufacturer (Section D): VENTANA MEDICAL SYSTEMS INC; 1910 e innovation park dr; tucson AZ 85755
• Manufacturer Contact: stacie-ann creighton ; 1910 e. innovation park drive; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 15610718
• MDR Text Key: 304602746
• Report Number: 2028492-2022-00010
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04015630981052
• UDI-Public: 04015630981052
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05342716001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1