Model Number G5A-80P1 |
Device Problems
Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 09/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The nurse was asked to send the aed to cardiac science for investigation.
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Event Description
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School nurse was called to the classroom for a student who had passed out and upon arrival found the student being support by a teacher.Nurse assisted moving the student to the floor.Student was unresponsive but breathing.Nurse was unable to palpate a pulse and the student was cold, clammy, and pale.Another teacher was sent for the aed and 911 was called.Aed pads were placed on the student and the aed analyzed the patient's rhythm, advised a shock, and a shock was delivered.Student became responsive after the shock, bp was normal, and hr was between 120 - 140.Ems arrived, assumed care, and transported the student to children's hospital er.Aed event log was downloaded and sent to a cardiologist at the hospital per request.The cardiologist notified the school rn that the student was in normal sinus rhythm during the event and a shock should not have been delivered.The patient survived.
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Event Description
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School nurse was called to the classroom for a student who had passed out and upon arrival found the student being support by a teacher.Nurse assisted moving the student to the floor.Student was unresponsive but breathing.Nurse was unable to palpate a pulse and the student was cold, clammy, and pale.Another teacher was sent for the aed and 911 was called.Aed pads were placed on the student and the aed analyzed the patient's rhythm, advised a shock, and a shock was delivered.Student became responsive after the shock, bp was normal, and hr was between 120 - 140.Ems arrived, assumed care, and transported the student to children's hospital er.Aed event log was downloaded and sent to a cardiologist at the hospital per request.The cardiologist notified the school rn that the student was in normal sinus rhythm during the event and a shock should not have been delivered.The patient survived.
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Manufacturer Narrative
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The customer's aed was received at cardiac science and the rescue data file was downloaded.Review of the data, which included cardiac science's medical director, concluded a shock had been delivered to a non-shockable rhythm.The patient's organized rhythm was determined to be shockable because the aed detected tall t waves and some p waves as peaks which resulted in a detected heart rate above the detection threshold.The aed correctly synchronized the shock and caused no proarrhythmic changes.Based upon information provided by the customer, the patient was unconscious when the shock was delivered.As part of the investigation, the aed was functionally evaluated and successfully passed testing to factory specifications.The aed will be serviced and returned to the customer.
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Search Alerts/Recalls
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