Model Number 866199 |
Device Problems
Signal Artifact/Noise (1036); Unable to Obtain Readings (1516)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation.
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Event Description
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It was reported to philips that there was an ecg failure error on screen.It's unknown whether there's patient involvement, request for such info was sent.There was no adverse event.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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Event Description
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It was reported to philips that there was an ecg failure error on screen.Device was in clinical use at time of event.However, no patient harm reported.There was no adverse event.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.
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Search Alerts/Recalls
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