Model Number 866199 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/07/2023 |
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 the display is getting blurred.Device was in clinical use but no reported patient nor user harm.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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Fse onsite checked and reconnected display cable to resolve the issue.Based on the information available and results of additional analysis, no further action is necessary at this time.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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Event Description
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Philips received a complaint on the efficia dfm100 defibrillator monitor indicating display is getting blurred.The device was not in clinical use at the time the issue was discovered.There was no reported patient impact / injury.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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Search Alerts/Recalls
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