Model Number 866199 |
Device Problems
Electrical /Electronic Property Problem (1198); Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2024 |
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 paddle exhibited damage.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 field service engineer (fse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 indicating that the external paddles were damaged.The fse evaluated the external paddles and found them damaged.The fse replaced the external paddles.The device function checked normal, and the system was returned to service.Based on the information available and the testing conducted, the cause of the reported problem was the external paddles.The reported problem was confirmed.The device was operational after repairs were completed.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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