Model Number 26915 |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Sensing Intermittently (1558)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Additional manufacuring narrative: other, other text: 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 the rad-5 was "not reading spo2 correctly" and "bpm [was] not accurate".Additionally, a "dropout with limited motion" was observed.No patient impact or consequences were reported.
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Event Description
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The customer reported the rad-5 was "not reading spo2 correctly" and "bpm [was] not accurate." additionally, a "dropout with limited motion" was observed.There were no patient impact or consequences 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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