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

Catalog Number 06917259001

Device Problem Power Problem (3010)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

A customer from switzerland reported that their he 600 instrument's pmad (power management and distribution) circuit board has been burnt.No harm is alleged.An investigation is being conducted to evaluate the customer¿s allegation.

Manufacturer Narrative

An investigation has been initiated and is on-going.A follow-up report will be submitted upon the completion of the investigation.Initial reporter facility name truncated due to character limit: (b)(6).

Manufacturer Narrative

Further investigation is needed to determine the root cause(s) of the alleged issue.No harm alleged.A new he-600 instrument was sent to the customer site.

Manufacturer Narrative

Investigation determined that the new he-600 instrument solved the issue.No harm alleged.No further issues were indicated by the customer.

• 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
• Manufacturer Contact: stacie-ann creighton ; 1910 east innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 14737211
• MDR Text Key: 301921094
• Report Number: 2028492-2022-00003
• Device Sequence Number: 1
• Product Code: KPA
• UDI-Device Identifier: 04015630976010
• UDI-Public: 04015630976010
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 06917259001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• 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