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

Catalog Number 06917259001

Device Problems Thermal Decomposition of Device (1071); Electrical Shorting (2926)

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

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

Capa has been initiated for the issue and root cause investigation is ongoing.Corrective and preventive measures will be implemented, as appropriate.(b)(4).

Event Description

A customer from (b)(6) reported an electrical short from the back of the he 600.The customer was instructed to turn off the instrument and ups.The field service engineer visited the lab, and found a cable from the ventilators was burned, as well as the insulating protection that was on top of the ventilators.Return of the customer materials confirmed the affiliate¿s observation that the instrument had a short circuit event within the 24vdc wiring harness powering the compressor chamber exhaust fans.No one was harmed or injured.

• 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 e innovation park dr; na; tuscon, AZ 85755 ; 9082537112
• MDR Report Key: 9049713
• MDR Text Key: 164257202
• Report Number: 2028492-2019-00017
• Device Sequence Number: 1
• Product Code: KPA
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: 510 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
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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: 08/16/2019
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1