Model Number 8900-4006 |
Device Problem
Sparking (2595)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2021 |
Event Type
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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Event Description
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Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), a spark was emitted from the electrode pad.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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The propadz radiolucent electrodes were returned to zoll medical corporation for evaluation.Inspection of the pads observed evidence that a spark occurred due to an air pocket between the pads and the patient.The electrodes were scrapped at zoll.Electrode labeling states the importance of good placement on the patient and provides instruction for proper electrode application technique.Poor adherence and/or air under the electrodes can lead to the possibility of sparking/arcing and skin burns.The instructions for use on the pro-padz radiolucent electrodes label states, "apply electrode by attaching one edge securely to the patient and rolling smoothly from that edge to the other.Be careful not to trap any pockets of air between the gel and skin." analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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