Model Number 28710 |
Device Problems
Device Alarm System (1012); Unexpected Shutdown (4019)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/20/2023 |
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.Device not returned.
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Event Description
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The customer reported the device is not alarming and won't stay on.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other, other text: the returned device passed the visual inspection and functional testing.The screen turns itself off after a few minutes which is by design, when the device is in "sleep mode".The device remains on and operational in this setting.Visual alarms are displayed during sleep mode, not audible.No issues were found with the power or audible alarms when tested while in "continuous mode".The device functioned as designed.
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Event Description
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The customer reported the device is not alarming and won't stay on.No patient impact or consequences were reported.
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Search Alerts/Recalls
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