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

Catalog Number	06917259001
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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).
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 2028492-2022-00003
• Device Sequence Number: 12196410
• Product Code: KPA
• UDI-Device Identifier: 04015630976010
• UDI-Public: 04015630976010
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 06917259001
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 10/25/2022; 03/28/2023
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 11/22/2022; 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown