MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS EVOTECH; ACCESSORIES, CLEANING, FOR ENDOSCOPE

Device Problems Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585); Sparking (2595)

Patient Problem No Information (3190)

Event Date 04/10/2015

Event Type  malfunction  

Event Description

Evotech machine experienced overheating issue.Staff smelled burning and observed smoke and sparks coming from fan.

• Brand Name: EVOTECH
• Type of Device: ACCESSORIES, CLEANING, FOR ENDOSCOPE
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 4758269
• MDR Text Key: 17588548
• Report Number: 4758269
• Device Sequence Number: 1
• Product Code: FEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2015

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
• Device Operator: Invalid Data
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2015
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1