Model Number 866199 |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
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 replacement of external plates.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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Based on the information currently available, there is no allegation of malfunction or defect of this device indicated in this record at this time.Good faith effort confirmed there was no malfunction and customer just inquired field safety notice.We should close this record as a non-complaint.
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Search Alerts/Recalls
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