Model Number M3535A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Death (1802); Loss Of Pulse (2562)
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Event Date 01/30/2018 |
Event Type
Death
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Manufacturer Narrative
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A follow up report will be submitted once the investigation is complete.Patient information requested, not yet received.
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Event Description
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It was reported to philips that the device analyzed the patient rhythm as shock advised, charged, and delivered a shock while in aed mode when the patient's rhythm was pulseless electrical activity (pea).The patient involved was reported in cardiac arrest, the device was connected to the patient by a special emergency response team of clinicians (crash team), and set in aed mode.While cpr was being performed, the defibrillator in the aed mode analysed the trace as shock advised.The aed subsequently charged and a shock was delivered, but a review of the patient's rhythm showed that the patient was in pea.The event summary shows that a "no shock advised" message was given by the device on two occasions during the incident., but the crash team did not recall hearing these events.The patient did regain consciousness but was then made "dnacpr" and subsequently died a few hours after arrest.
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Event Description
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It was reported to philips that the device analyzed the patient rhythm as shock advised, charged, and delivered a shock while in aed mode when the patient's rhythm was pulseless electrical activity (pea).The patient involved was reported in cardiac arrest, the device was connected to the patient by a special emergency response team of clinicians (crash team), and set in aed mode.While cpr was being performed, the defibrillator in the aed mode analysed the trace as shock advised.The aed subsequently charged and a shock was delivered, but a review of the patient's rhythm showed that the patient was in pea.The event summary shows that a "no shock advised" message was given by the device on two occasions during the incident., but the crash team did not recall hearing these events.The patient did regain consciousness but was then made "dnacpr" and subsequently died a few hours after arrest.The fse reported that the issue was not confirmed and there was no trouble found with the device.The device passed all performance assurance testing and was placed back in service.
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Search Alerts/Recalls
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