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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTTNAUER CHAMBER BRITE STERILIZER CLEANER, UNIDOSE-SINGLE USE PACKAGES UNK AUTOCLAVE STEAM STERILIZER

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TUTTNAUER CHAMBER BRITE STERILIZER CLEANER, UNIDOSE-SINGLE USE PACKAGES UNK AUTOCLAVE STEAM STERILIZER Back to Search Results
Device Problems Label (862); Device Reprocessing Problem (1091); Device Emits Odor (1425); Packaging Problem (3007)
Patient Problem Respiratory Distress (2045)
Event Date 05/02/2018
Event Type  Injury  
Event Description

Private dental office. Use tuttnauer steam sterilizer (table top) model 2340m. Monthly maintenance to clean with product "chamber brite" also tuttnauer). Completion of cleaning cycle with chamber brite, pungent burnt plastic smell was emitted into the office. An employee hygienist who was near to the unit went into respiratory distress. The 911 was called, employee taken to hospital by paramedics and received out patient care. Researching online showed possible causes are single dose cleaning packets have too much chemical for smaller autoclaves. Also, if cleaner is added to an autoclave that is already warm, , then the heat could react with chemical. Problem is lack of information on the cleaning packets (there is none). If references to follow cleaning instructions in the manual. This lack of product labeling (chamber brite) makes errors in cleaning possible.

 
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Brand NameCHAMBER BRITE STERILIZER CLEANER, UNIDOSE-SINGLE USE PACKAGES UNK
Type of DeviceAUTOCLAVE STEAM STERILIZER
Manufacturer (Section D)
TUTTNAUER
MDR Report Key7493953
MDR Text Key107788641
Report NumberMW5077040
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 05/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/07/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/07/2018 Patient Sequence Number: 1
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