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 03/16/2022 |
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 seen from the electrode pads.Complainant indicated that the clinician obtained another device to continue treating the patient.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 stat padz and associated device were returned to zoll medical corporation.The customer's report was verified and attributed to poor coupling.Review of the device log shows a large difference between the measured 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.Poor adherence and/or air under the electrodes can lead to the possibility of sparking/arcing and skin burns.Analysis for reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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