Model Number 866199 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.
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Event Description
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It was reported to philips that the adapter cable exhibited damage.There was no reported patient involvement.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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Manufacturer Narrative
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Subsequent information received indicated that there was no reported issue with the device, parts were replaced as part of a field safety notice (fsn) implementation (ref.Fsn 2022-cc-ec-010_efficia pad adapter cable_hkg¿ and fsn 2021-cc-ec-023 efficia external paddles).Therefore, this issue is considered non-reportable as there was no death or serious injury reported, and there was no report of a device malfunction.Regulatory reporting is no longer applicable.
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Search Alerts/Recalls
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