Model Number 866199 |
Device Problem
Device Fell (4014)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/30/2023 |
Event Type
malfunction
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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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Event Description
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It was reported to philips that device has damaged rear and lower body due to fall.There¿s 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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Event Description
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This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 indicating that the device case damaged due to fall.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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H3 other text : multiple attempts were made to obtain the device evaluation, repair, and operational status with no approval from the customer.No further information was provided.
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Search Alerts/Recalls
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