Model Number 866199 |
Device Problems
Material Integrity Problem (2978); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
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 repported to philips that the efficia dfm100 exhibited damage on the paddle.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 a philips call center personnel and field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 defibrillator indicating that the paddle is damaged.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the external paddle is damaged.The fse evaluated the component onsite and replaced the paddles.The faulty component is not expected for return.The device was returned to service and remains at the customer site.Based on the information available, the cause of the reported problem was component failure.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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