Model Number 866199 |
Device Problems
Display or Visual Feedback Problem (1184); Output Problem (3005)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/19/2024 |
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 efficia dfm100 defibrillator prompts an ecg fault.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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This report is based on information provided by philips remote service engineer (rse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 indicating an electrocardiograph (ecg) fault.The user worked with the rse and was guided in performing an operational check.Once the operational check was completed the device returned to normal operation.No further actions are needed at this time.Based on the information available and the testing conducted, the cause of the reported problem is unknown.The reported problem was not confirmed.The device was operational after completing an assisted operational check.The investigation was not able to find the cause of the problem, if additional information is received the complaint file will be reopened.H3 other text : remote support provided.
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Search Alerts/Recalls
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