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 05/10/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Evaluation is in progress, but not yet concluded.The fsr troubleshot the problem and determined the temperature/pressure printed circuit board (pcba) was at fault.The fsr replaced the temperature/pressure pcba.The unit operated to manufacturer's specifications.The temperature/pressure pcba was returned to the manufacturer for further evaluation.
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Event Description
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The field service representative (fsr) reported that during preventive maintenance (pm) of the device, the channel a of arterial monitor would not display temperature.It would only display dashes.There was no patient involvement.
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.During laboratory analysis, product surveillance technician (pst) observed that a damaged input connector caused the channel a input to not display temperature.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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