Model Number 22545 |
Device Problems
Human-Device Interface Problem (2949); Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/27/2021 |
Event Type
malfunction
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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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Event Description
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The customer reported the touchscreen was not responding adequately and is turning off on its own.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: the returned device was evaluated.External visual inspection found no damage.The unit was able to power on and obtain measurements with all the enabled parameters.The touchscreen was not responsive on all segments of the display.The device was left powered on taking measurements for one hour and no failures were observed, device remained on throughout duration of the test.Internal inspection found contamination on the touchscreen flex cable pad which caused the touchscreen to be unresponsive.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.
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Event Description
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The customer reported the touchscreen was not responding adequately and is turning off on its own.No patient impact or consequences were reported.
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Search Alerts/Recalls
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