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 upon completion of the investigation.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 gives alarm in aed mode.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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Event Description
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It was reported to philips that the device gives alarm in aed mode.There was no patient involvement.The customer called and spoke with a philips remote service engineer (rse).There was no malfunction with the device and customer had no allegation of device malfunction.No malfunction of device alleged.The device remains at the customer site and no further evaluation is required at this time.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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