Model Number 866199 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/31/2023 |
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 operation check takes more time than normal.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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Manufacturer Narrative
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Based on the information available, issue is resolved after reloading of software.No capa will be initiated based on this record; a corrective action will be initiated if a trend is discovered through periodic monitoring.Device is working fine as per manufacturer's specifications after reloading of software.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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