Model Number 27498 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Additional manufacuring narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.H3 other text : device not returned.
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Event Description
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The customer reported the radical -7 device turns off.There were no patient impact or consequences reported.
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Manufacturer Narrative
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Additional manufacuring narrative: other, other text: the returned device was evaluated.During testing, the battery was observed to be bloated however the device did not shut down by itself.The reported power issue was not confirmed.
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Event Description
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The customer reported the radical -7 device turns off.There were no patient impact or consequences reported.
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Search Alerts/Recalls
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