Model Number 866199 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/09/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).A follow up report will be submitted upon completion of the investigation.
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Event Description
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Philips received a complaint on the defibrillator indicating that the device had ecg equipment error.There was no 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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Onsite evaluation confirmed the issue.Operational check was performed and hardware error logs were checked.It was determined the therapy pca (printed circuit board) was faulty.The therapy pca was replaced resolving the issue.The engineer confirmed the device was operational after repairs were completed and the device remains at the customer site.The component was replaced to resolve the issue and the faulty component was requested to be returned for investigation by philips emergency care (ec) failure analysis.If the component is received by philips, the complaint will be reopened and the device will be evaluated.
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Search Alerts/Recalls
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