Model Number 866199 |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/14/2024 |
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 efficia dfm100 exhibited a battery failure.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 remote service engineer (rse) and philips field service engineer (fse) has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating a battery failure.The event was outside of use and there was no reported patient nor user harm.Available details indicate that upon performance testing, the device was emitting a series of continuous chirps and issued an error message to replace the battery.The device was evaluated onsite and the fse installed a new battery resolving the issue.The failed component is not expected for return.The device is returned to full functionality and remains at the customer site.Based on the information available and the testing conducted, 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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