MAUDE Adverse Event Report: MIDMARK CORPORATION MIDMARK M11 AUTOCLAVE; MIDMARK M11 AUTOCLAVE STERILIZER, STEAM

Model Number M-11-040

Device Problems Thermal Decomposition of Device (1071); Product Quality Problem (1506)

Patient Problem Insufficient Information (4580)

Event Type  No Answer Provided  

Event Description

New midmark m11 autoclave has the potential to cause an office fire.Manufacture update was not disclosed prior to purchase or use.Our office purchased a new midmark m11 autoclave.Our henry schein service technician did the install and initial testing, there were no new operation updates or changes to the usage protocol.This autoclave had been in use for a couple months when it burn/charred the packaging that was being sterilized.Our henry schein tech did testing to the autoclave a d found na errors or issues with it.Due to the risk of fire we returned this autoclave to henry schein, upon further conversations with henry schein and a midmark representative, it came to light that there had been a change made to the drying cycle of the new models of the midmark m11 autoclave and there had been other offices experiencing the same issue.The solution from midmark is to not use the bottom try when sterilizing, use cassettes or racking.This significantly alters the efficiency in which we can utilize our sterilizers.This information regarding the change to the drying cycle as not disclosed to our office prior to purchase or use of the autoclave and could have resulted in a fire.

• Brand Name: MIDMARK M11 AUTOCLAVE
• Type of Device: MIDMARK M11 AUTOCLAVE STERILIZER, STEAM
• Manufacturer (Section D): MIDMARK CORPORATION
• MDR Report Key: 12067072
• MDR Text Key: 258955089
• Report Number: MW5102149
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M-11-040
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1