Device Problems
Device Alarm System (1012); Device Stops Intermittently (1599); Invalid Sensing (2293); Device Operates Differently Than Expected (2913)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 12/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information could not be obtained due to country privacy laws.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare¿s investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.
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Event Description
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The hospital reported that, the scavenging sensor in various operating room showed different values.In urology room, the alarm activates intermittently at 45 lt/min, while in surgery room, the alarm is permanently active at 55 lt/min.There was no reported patient injury.
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Manufacturer Narrative
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The ge healthcare service representative performed a checkout of the system and confirmed the reported issue.The software was updated to service pack 04 to resolve the reported issue.
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Manufacturer Narrative
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Ge healthcare product engineering reviewed this event and determined that this issue will not impact the machine function and ventilation will not be impacted.Thus, this case has been assessed as not reportable.
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Search Alerts/Recalls
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