Model Number 866199 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/21/2023 |
Event Type
malfunction
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Event Description
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It was reported to philips that device has error.Patient involvement information is currently unknown, but no reported adverse event.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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A follow up report will be submitted upon completion of the investigation.
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Manufacturer Narrative
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This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 indicating that a device error.It was originally determined a reportable event, reports were submitted, then further evaluation determined that this was not reportable due to this is not a normal repair work, but a preventive software update.There was no device malfunction.H3 other text : further evaluation determined that this was not reportable due to this is not a normal repair work, but a preventive software update.
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Event Description
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It was originally determined a reportable event, reports were submitted, then further evaluation determined that this was not reportable due to this is not a normal repair work, but a preventive software update.There was no device malfunction.
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Search Alerts/Recalls
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