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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PELTON & CRANE MAGNA-CLAVE; STERILIZER

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PELTON & CRANE MAGNA-CLAVE; STERILIZER Back to Search Results
Model Number MC
Device Problems Overheating of Device (1437); Smoking (1585)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2016
Event Type  malfunction  
Manufacturer Narrative
Pelton & crane is currently in the process of scheduling a joint review with the insurance company.A follow-up report will be submitted once the review takes place and the evaluation completed.
 
Event Description
It was initially reported to pelton & crane by an insurance company that a pelton & crane magna-clave sterilizer caught on fire at their insured business property.A follow-up call with the doctors office indicated that there was no fire but rather the dr.Claimed the sterilizer had overheated while sitting on a wood laminate countertop resulting in smoke coming from underneath the sterilizer.There were no injuries reported.
 
Manufacturer Narrative
Pelton & crane attended a joint review with the insurance company's mechanical / forensic expert.Upon evaluation, it was confirmed by both parties that the sterilizer did not catch on fire as initially reported by the insurance carrier but rather the wood laminate countertop the sterilizer was sitting on had started to char and smoke.Upon further investigation, pelton & crane noticed the sterilizer had not been properly maintained for quite some time by the doctors office as the chamber water filters, chamber, and water bellows assembly were extremely filthy.Also the heating elements were rusted and the overheat protector was not properly functioning.The insurance company's mechanical / forensic expert also confirmed the sterilizer had not been properly maintained.These components that were not maintained can cause the water to not properly fill and/or stay in the sterilizer chamber during a sterilizing cycle as well as to shut down the heating elements if the unit gets too hot due to lack of water.Therefore, by continually using a non-maintained sterilizer on a wood laminate countertop for a prolonged period of time led to the incident reported.This concludes the evaluation.
 
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Brand Name
MAGNA-CLAVE
Type of Device
STERILIZER
Manufacturer (Section D)
PELTON & CRANE
11727 fruehauf drive
charlotte NC 28273
Manufacturer (Section G)
PELTON & CRANE
11727 fruehauf drive
charlotte NC 28273
Manufacturer Contact
frank ray
11727 fruehauf drive
charlotte, NC 28273
7045877227
MDR Report Key6301591
MDR Text Key66763574
Report Number1017522-2017-00004
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 Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMC
Device Catalogue NumberMC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/03/2017
Initial Date FDA Received02/03/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2006
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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