Model Number 866199 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/01/2023 |
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 charge button is not working.Patient involvement information is currently unknown, but no reported adverse event.We are considering this to be a serious injury because it is not known if the patient procedure was life-saving therapy nor if the treatment was interrupted.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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This report is based on information provided by a philips customer service agent and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 defibrillator monitor indicating that the charge button is not working.It is unknown if the event occurred during use, but there was reportedly no adverse event and no adverse event to the patient or user.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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