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

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).

• Brand Name: TABLE TOP STERILIZER
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): TUTTNAUER USA CO., LTD
• MDR Report Key: 7818699
• MDR Text Key: 118528856
• Report Number: MW5079403
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EZ 11 PLUS
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1