MAUDE Adverse Event Report: ASP GLOBAL MANUFACTURING GMBH STERRAD; STERILIZER, CHEMICAL

Device Problems Fire (1245); Smoking (1585)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2023

Event Type  Injury  

Event Description

Sterrad lamp control caught fire and started smoking.This filled the area with smoke and would have caused major damage to the facility and millions of dollars in supplies and equipment.

• Brand Name: STERRAD
• Type of Device: STERILIZER, CHEMICAL
• Manufacturer (Section D): ASP GLOBAL MANUFACTURING GMBH
• MDR Report Key: 16436275
• MDR Text Key: 310159978
• Report Number: MW5115140
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening