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

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.

• 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 Key: 6301591
• MDR Text Key: 66763574
• Report Number: 1017522-2017-00004
• 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: 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 Number: MC
• Device Catalogue Number: MC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 02/03/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1