Model Number 8900-2106-01 |
Device Problem
Arcing of Electrodes (2289)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
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Event Description
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Complainant alleged that while attempting to treat a patient (age & gender unknown), an arc was heard 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 evaluated the device and the device performed to specification.Inspection of the pads did find discoloration on the conductive plates indicating a discharge occurred.Review of the device clinical data showed one shock event for the reported event date and the output was within specification for the measured impedance.There are no abnormalities or errors observed in the clinical data.Electrode labeling calls out the importance of good placement on the patient and provide instructions for proper electrode application technique.Poor adherence and /or air under the electrodes can lead to the possibility of arcing and skin burns.Good skin preparation does not guarantee a burn will not occur and burns from defibrillation is an expected risk.Analysis of reports of this type has not identified an increase in trend.
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Search Alerts/Recalls
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