Model Number 861290 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Shock (2072)
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Event Type
Injury
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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 that the device only delivered 1 of 2 or 4 shocks attempted during cardioversion.The alleged failure was observed while the device was in use on a patient.Investigation of patient status & if there was patient harm is currently pending.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 that the device only delivered 1 of 2 or 4 shocks attempted during cardioversion.The alleged failure was observed while the device was in use on a patient.There was no harm reported regarding the involved patient.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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