Model Number 16413 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/16/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The field service representative (fsr) found the temperature/pressure pc board was faulty.A loaner monitor was installed and release testing completed.The unit operated to the manufacturer's specifications.The suspect part was returned to the manufacturer for further evaluation.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, the arterial monitor was not displaying temperature values.The cardioplegia (cpg) monitor was used for temperature monitoring.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 was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the monitor to not display temperatures because of a defective temperature/pressure board.The monitor was powered on, and after initial check no temperatures were displayed.The temperature/pressure board was temporarily replaced with a board from a lab use only arterial monitor and monitor then displayed temperatures.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.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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Search Alerts/Recalls
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