Model Number 25480 |
Device Problem
High Readings (2459)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2022 |
Event Type
malfunction
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Event Description
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The customer reported high sphb figure.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the product is received for evaluation or new information is obtained, a follow up report will be submitted.
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Event Description
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The customer reported high sphb figure.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacuring narrative: the returned device was evaluated.During evaluation the device passed all visual and functional testing.During simulation testing, the device passed manual and preset conditions and provided accurate measurements.The unit was found to visually and audibly alarm during alarm conditions.The unit was determined to be functioning as designed.
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Search Alerts/Recalls
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