Catalog Number 190610 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental medwatch report will be submitted upon completion of the investigation.
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Event Description
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A user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
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Manufacturer Narrative
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Plant investigation: the device and component were not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.However, an investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure.A device is not released if it does not meet requirements or is nonconforming.In addition, the device record review confirmed the labeling, material, and process controls were within specification.
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Event Description
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A user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
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Event Description
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A user facility biomedical engineer (biomed tech) reported a discolored power cord plug and confirmed there was no patient involvement and no injury occurred.The biomed tech stated he was requested to perform an inspection on the machine and noted the power cord appeared discolored and burnt at the plug.The biomed tech stated the discovered power cord was replaced and confirmed no smoke or visible flames were reported from the power plug.The biomed tech the machine functioned as intended prior to the observation.No damage to the machine or receptacle was noted, and no burning smell, smoke or visible flame was reported as a result of the reported damaged power cord.The biomed tech stated the power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was available to be returned for evaluation.The machine serial number was to be provided by the biomed tech.
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Search Alerts/Recalls
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