Model Number 4003-9 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been returned to the local facility but has not yet been received at the main office for evaluation.Once the device has been returned and investigated, a follow-up report will be submitted.The initial reporter zip code exceeded the maximum number of allowable digits, the zip code is as follows: (b)(6).
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Event Description
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The customer reported sensor not working properly.During a resuscitation it took 8 minutes and 3 different sensors before an accurate saturation was picked up.This is not the first time that a sensor of this type has been defective and not worked during a crucial emergency situation.No patient impact or consequences were reported.
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Manufacturer Narrative
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Additional manufacturing narrative: other, additional manufacturing narrative (if other): the returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.When the sensor was connected to a masimo monitoring device, the device was able to generate an error message.The unit was determined to be functioning as designed.The initial reporter zip code exceeded the maximum number of allowable digits, the zip code is as follows: (b)(6).
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Manufacturer Narrative
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The returned sensor was evaluated.During evaluation the sensor passed all visual and functional testing.When the sensor was connected to a masimo monitoring device, the device was able to generate an error message.The unit was determined to be functioning as designed.The initial reporter zip code exceeded the maximum number of allowable digits, the zip code is as follows: (b)(6), field: age at time of event was updated from (b)(6).
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Search Alerts/Recalls
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