Model Number 861290 |
Device Problem
Defibrillation/Stimulation Problem (1573)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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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.
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Event Description
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It was reported to philips that the device had a problem on (b)(6) 2020 when it was used during complications with the patient.The problem that occurred: during unsynchronized defibrillation, after proper charging the equipment, the shock was not applied when pressing the blades and, when pressing the red button of the monitor, there was a delay of approximately 10 seconds for the shock to be released.The device was reported to be in use on a patient, causing a delay in therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.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 that there was a delaying printing configuration with a 10 second delay, and reconfigured for 0 second delay in operational check.The device was in use on a patient, however there was no adverse event to the patient or user.
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Search Alerts/Recalls
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