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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION-DISTRIBUTION CENTER CREST SONIC CLEANER
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STERIS CORPORATION-DISTRIBUTION CENTER CREST SONIC CLEANER Back to Search Results
Device Problems Fire (1245); Smoking (1585)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2014
Event Type  malfunction  
Event Description
The user facility reported that their crest sonic cleaner caught fire.The fire and smoke was extinguished and steris was contacted.No injuries or procedural delays or cancellations were reported.No third party responders were contacted.
 
Manufacturer Narrative
The user facility stated that damage was limited to the sonic cleaner only.A steris svc tech arrived onsite and found the unit to be inoperable.The tech stated that during the time of the reported event the control had become hot, melting the wiring and components.The tech noted damage to the front corner of the cleaner from hosp personnel bumping transfer carts into the unit.This damaged area was in the same that had the electrical fire.The tech removed the cleaner from svc and the user facility received a new crest sonic cleaner which was installed on (b)(6) 2014.
 
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Brand Name
CREST SONIC CLEANER
Type of Device
SONIC CLEANER
Manufacturer (Section D)
STERIS CORPORATION-DISTRIBUTION CENTER
6100 heisley rd.
mentor OH 44060
Manufacturer Contact
kathryn cadorette
5960 heisley rd
mentor, OH 44060
4403927231
MDR Report Key4383691
MDR Text Key5361742
Report Number3003950207-2014-00002
Device Sequence Number1
Product Code FLG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
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
Date Manufacturer Received11/18/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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