Catalog Number 190713 |
Device Problem
Thermal Decomposition of Device (1071)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/11/2017 |
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 burnt power cord.There was no patient involvement or harm reported.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no injury occurred.The clinic manager confirmed no burning smell, smoke or visible flames were reported from the power plug, and the machine functioned as intended.The power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was returned by the biomed tech for evaluation.
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Manufacturer Narrative
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Plant investigation: the power cord was received with heat damage on both hot and neutral prongs of the plug.A microscopic view shows signs of pitting on both sides of the damaged prongs.Measurements were taking on each wires of the power cord which have continuity and the resistance between the wires are open as expected.The power cord was installed onto a test machine and plugged into an outlet which was tight and cannot be easily unplugged.The test machine powered on and a self-test was completed without failures.There were no additional damage on the plug during testing.The reported physical damage on the power cord is confirmed.An investigation of the device manufacturing records was also 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.The damaged power cord was confirmed.
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Event Description
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A user facility biomedical engineer (biomed tech) reported a burnt power cord.There was no patient involvement or harm reported.Additional follow-up was made with the clinic manager, who confirmed there was no patient involvement and no injury occurred.The clinic manager confirmed no burning smell, smoke or visible flames were reported from the power plug, and the machine functioned as intended.The power plug was replaced as a precaution and the machine was placed back in service without any further issue.The power cord was returned by the biomed tech for evaluation.
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Search Alerts/Recalls
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