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 supply cable was returned with burn damage to the power plug and the cable's white wire/plug.Plastic was melted around the terminal of the white wire in the power plug and the terminal had pitting.The power supply cable was measured to have good continuity and a test machine completed a self-test program without failure with the cable installed.The pitting on the power plug terminal indicates arcing within the outlet used at the customer¿s facility.Hospital grade outlets are required with the use of the t machine.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 cable 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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