Model Number 8900-4006 |
Device Problem
Sparking (2595)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
|
|
Event Description
|
Complainant alleged that while attempting to cardiovert a patient (age & gender unknown), an arc was seen from the electrode pads.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
|
|
Manufacturer Narrative
|
The pro-padz solid gel radiolucent electrodes were returned to zoll medical corporation open and used.Visual inspection found a presence of hair on the adhesive of the electrodes and discoloration on the conductive plates indicating the occurrence of discharge.The pictures provided by the customer do show evidence that arcing or sparking occurred.The picture also indicates that the patient was not properly prepped as there is still a lot of unshaved hair on the patient's chest after the electrodes were used and removed from the patient.This investigation was closed as improper patient preparation prior to the application of the electrodes.Instructions for use on the pro-padz radiolucent electrodes label calls out the importance of good placement on the patient and states: "clip excess air and wipe the skin dry." electrode labeling provides 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 that 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.
|
|
Search Alerts/Recalls
|