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 10/12/2023 |
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 system failure.Additional information has been requested.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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Philips bench evaluated the device and confirmed that the device was starting in service mode due to a malfunction of the processor.Philips bench provided part number and pricing of this replacement part to the customer.However, the customer opted not to have the device repaired and the device was returned unrepaired to the customer.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the processor.The reported problem was confirmed.Philips bench provided part number and pricing of this replacement processor to the customer.However, the customer opted not to have the device repaired and the device was returned unrepaired to the customer.It has been concluded 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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This report is based on information provided by philips bench technician and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that the device had a system failure.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 bench technician and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator indicating that the device had a system failure.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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Search Alerts/Recalls
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