Model Number 500AVHCT |
Device Problems
Thermal Decomposition of Device (1071); Smoking (1585)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/20/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Per the manufacturer's subsidiary, the side of the printer had high heat and smelled as if the motor was burnt.The user facility continued to use the device without the printer.
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Event Description
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, there was smoke and a burnt odor.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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Manufacturer Narrative
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The reported complaint could not be confirmed.The service repair technician (srt) was not able to duplicate the reported issue.The srt installed a new printer.The unit operated to the manufacturer's specification.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed the printer to work as intended.There was no obvious or apparent ¿burnt¿ smell from the printer, printer wires not charred, no evidence that motor got extremely hot, no dis-colorization of the motor itself or of its wires due to excessive heat.
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Event Description
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Per clinical review: during a cardiopulmonary bypass (cpb) procedure, the clinical engineers/perfusionists saw smoke generation and a burnt odor near the location of the printer on the blood parameter monitor (bpm).The clinicians noted that it was very little smoke and that the area near the printer on the monitor was hot to the touch.They did not changed out the monitor, they continued the case without the use of the printer.The printer is an ancillary part that if the printer fails, the unit can function fully without any concern.The incident did not delay the surgical procedure.There was no harm to either the patient or the clinician due to the generation of a small amount of smoke.There was no blood loss associated with the event.
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Manufacturer Narrative
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During additional laboratory analysis, the product surveillance technician (pst) tested the power supply and it worked as intended.No damaged components or burning was noted.
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Search Alerts/Recalls
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