Model Number 25052 |
Device Problem
Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/1901 |
Event Type
malfunction
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Event Description
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The customer reported the radical-7 turns on and off during use.There was no patient impact or consequence reported.
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Manufacturer Narrative
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Additional manufacturing 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.
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Manufacturer Narrative
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Additional manufacturing narrative: other, other text: the returned device was evaluated.There was no damage or defects observed during visual inspection.The device could be powered on and off using ac and dc power.Alarm conditions were audible and visual.The reported power issue was not observed during lab testing.
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Event Description
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The customer reported the radical-7 turns on and off during use.There was no patient impact or consequence reported.
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Search Alerts/Recalls
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