Model Number R SERIES |
Device Problem
Arcing of Electrodes (2289)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2023 |
Event Type
malfunction
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Event Description
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Complainant alleged that while attempting to cardiovert a 76-year-old female patient, an arc was seen from the electrode pads.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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Manufacturer Narrative
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Zoll medical corporation has received the product and will be providing a supplemental report when our investigation is completed.
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Manufacturer Narrative
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The device was returned to zoll medical corporation for evaluation.The device was put through extensive testing bench handling, impedance testing, and defibrillation cycling without duplicating a malfunction.The multifunction cable and electrode pads used during the event were not returned to zoll as part of the investigation.A review of the device log shows a large difference between the measured and energy delivered impedances which is evidence of poor coupling between the patient and the electrodes being used.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Zoll recommends that patients are cleaned and hair is clipped prior to applying electrode pads to assure good coupling of electrode to skin contact.Poor adherance and/or air under the electrodes can lead to the possibility of arcing and skin burns.The device was recertified and returned to the customer.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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