Model Number 866199 |
Device Problem
Power Problem (3010)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/20/2021 |
Event Type
malfunction
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Event Description
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It was reported to philips that the 18 v therapy supply was out of range.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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The customer has ordered power supply and therapy pca to solve the issue.The device remains at the customer site and no further evaluation is required at this time.The therapy pca was returned "18-volt therapy supply out of range." this was not verified in failure analysis lab testing.Data generated by this investigation will be logged for trending analysis.Further device investigation has been completed and previously reported investigation results have been confirmed.
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Manufacturer Narrative
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The customer has ordered power supply and therapy pca to solve the issue.The device remains at the customer site and no further evaluation is required at this time.The therapy pca was returned "18-volt therapy supply out of range." this was not verified in failure analysis lab testing.Data generated by this investigation will be logged for trending analysis.Further device investigation has been completed and previously reported investigation results have been confirmed.¿.
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Search Alerts/Recalls
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