Model Number 861290 |
Device Problem
Device Alarm System (1012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be submitted once the investigation is completed.(b)(4).
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Event Description
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It was reported to philips that the device does not stop beeping.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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Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Event Description
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It was reported to philips that the device does not stop beeping.It was reported to philips that the alleged failure was observed while the device was in use on a patient.However, no adverse patient impact was reported by the customer.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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