Model Number 27977 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/22/2023 |
Event Type
malfunction
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Event Description
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The customer reported the rad-g "turns on and off on its own." there was no patient impact or consequence reported.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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Additional manufacuring narrative: other, other text: the returned rad-g was evaluated.The device intermittently powered on then powered off shortly after powering on.This was due to shorting inside the on/off power button which created an electrical short across the button and resulted in the button being activated even when not physically pressed.
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Event Description
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The customer reported the rad-g "turns on and off on its own." there was no patient impact or consequence reported.
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Search Alerts/Recalls
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