Model Number 8220 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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The reported issue that the device had dim segment on the display could not be confirmed; no product or device logs were returned for investigation.No device history or qn search was performed since no source device serial number was reported by the customer.The alaris spo2 module is used for monitoring only.The file may be closed based on the above facts.The customer stated that there was no patient involvement.Customers received notification of the field action.The reported issue of a dim segment is confirmed based on the field action.Device repair or returns are handled within the scope of the field action.Device was not returned to manufacturing facility.
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Event Description
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(1) dim segment on led display spco2.Npr - no product returned.It was reported that the spco2 device dim segment on the led display is being replaced.Although requested here was no additional information provided by the customer at this time.
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Event Description
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(1) dim segment on led display spco2.Npr - no product returned.It was reported that the spco2 device dim segment on the led display is being replaced.Although requested here was no additional information provided by the customer at this time.
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Manufacturer Narrative
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The reported issue that the device had dim segment on the display could not be confirmed; no product or device logs were returned for investigation.No device history or qn search was performed since no source device serial number was reported by the customer.The alaris spo2 module is used for monitoring only.The file may be closed based on the above facts.The customer stated that there was no patient involvement.Customers received notification of the field action.The reported issue of a dim segment is confirmed based on the field action.Device repair or returns are handled within the scope of the field action.
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Search Alerts/Recalls
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