Model Number 500AVHCT |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The reported complaint was confirmed.Per the srt, during oven testing when the bpm was held in a 20 degree celsius environment it was reading 7.8 degrees celsius which is outside of the specification range.The srt replaced the venous bpm probe.The unit operated to the manufacturer's specifications.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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Event Description
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The service repair technician (srt) reported that during testing of the device at the service center, the venous blood parameter monitor (bpm) probe failed measured temperature accuracy testing.There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.Per the srt, during oven testing when the bpm was held in a 20 degree celsius environment it was reading 7.8 degrees celsius which is outside of the specification range.The srt replaced the venous bpm probe.The unit operated to the manufacturer's specifications.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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Event Description
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The service repair technician (srt) reported that during testing of the device at the service center, the venous blood parameter monitor (bpm) probe failed measured temperature accuracy testing.There was no patient involvement.
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Search Alerts/Recalls
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