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Model Number MCH-1000(M) |
Device Problems
Insufficient Cooling (1130); Crack (1135); Smoking (1585); Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
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Event Date 06/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Upon inspection of the suspect device, it was found that the heating element failed, started overheating, and melted the adjacent pvc, resulting in the "smell of smoke" that the customer experienced.Through further investigation, it was determined that the heating element failed due to a degradation in the material, causing the heating element to not perform according to specifications.
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Event Description
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Customer reports that the unit started smelling like smoke while plugged into a power strip and during use on a patient.They also report that the unit will no longer cool.
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Event Description
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Customer reports that the unit started smelling like smoke while plugged into a power strip during use on a patient.They also report that the unit will no longer cool.
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Manufacturer Narrative
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The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.A patient was involved during the malfunction, but no information was given about the patient, or if the device affected the patient.During the investigation, cardioquip identified the heaters to be the source of the malfunction.The heaters failed due to degradation of the metal casing causing them to overheat, melt nearby pvc, and produce a smoking odor.The nonfunctioning components were replaced, and the device passed final inspection and is fully functional.
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Search Alerts/Recalls
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