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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TUTTNAUER USA CO., LTD TABLE TOP STERILIZER STERILIZER, STEAM

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TUTTNAUER USA CO., LTD TABLE TOP STERILIZER STERILIZER, STEAM Back to Search Results
Model Number EZ 11 PLUS
Device Problems Defective Component (2292); Temperature Problem (3022); Fail-Safe Did Not Operate (4046)
Patient Problem No Information (3190)
Event Date 08/08/2018
Event Type  Malfunction  
Event Description

During regular cycle, the table top sterilizers failed safe. Evaluation of them showed that water pump is defective. The pump is furnished as part of sterilizers should be used with water which has max temperature 25 degree celsius. But actual water temperature is greater 65 degree celsius. Both models of tottnauer sterilizers have same pumps which don't meet sterilizers design requirement. Pump model is e, type (b)(4).

 
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Brand NameTABLE TOP STERILIZER
Type of DeviceSTERILIZER, STEAM
Manufacturer (Section D)
TUTTNAUER USA CO., LTD
MDR Report Key7818699
MDR Text Key118528856
Report NumberMW5079403
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 08/14/2018
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberEZ 11 PLUS
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No Answer Provided
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

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