Model Number 23785 |
Device Problem
Inappropriate or Unexpected Reset (2959)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2020 |
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 device turns off even though the battery is fully charged.No patient impact or consequences were reported.
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Manufacturer Narrative
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The returned device was evaluated.External visual inspection found no damage.The device was able to power on using both ac and battery power.After boot up the device goes into a ten beep watchdog alarm.In this condition the device is unable to obtain measurements.Internal inspection found contamination on the interface connector pins, this contamination would prevent proper contact with the docking station.Additionally a short was identified on pins 1 and 6 of the u21 component of the system circuit board.A service history record review reveals that this unit was in the field for over six (6) 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 device turns off even though the battery is fully charged.No patient impact or consequences were reported.
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Search Alerts/Recalls
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