Model Number 8900-0221-01 |
Device Problems
Mechanical Problem (1384); Arcing of Electrodes (2289)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 cardiovert a patient (age & gender unknown), an arc was seen coming 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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This supplemental medwatch report is reporting the evaluation of the device and correcting information submitted on the initial medwatch report.Evaluation: the onestep basic electrode pads were returned to zoll medical corporation.A visual inspection found that the apex pad was missing and appeared to have been physically removed.The foam was disassembled in an attempt to determine if the pads had been assembled correctly and there were no discrepancies found.The pad was scrapped.The customer's report of exposed wire was observed, however, it cannot be confirmed that it led to a spark/arc.The front pad was evaluated and confirmed a wire is exposed in the through hole.There are no signs of an arc or spark, overheating, or evidence that an arc occurred through the exposed shorting wire.Electrodes from retained samples of the same lot number 1420 were investigated.Evaluation of the electrodes did not reveal any irregularities that would have contributed to the reported event.Analysis of reports of this type has not identified an increase in trend.
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Event Description
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Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), an arc was seen coming from the electrode pads and a wire had become exposed from the electrode pad.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
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Search Alerts/Recalls
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