Model Number 866199 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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Philips received a complaint on the defibrillator indicating that the device needs corrective evaluation.Information regarding specified malfunction has been requested.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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(b)(6).A follow up report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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The rse provided a quote for diagnostic service, however, we are unable to confirm the final disposition of the device because the customer did not accept the quote.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.
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Search Alerts/Recalls
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